Optical Cable Corporation – Quality Assurance Technician – Plano, TX

Optical Cable Corporation – Quality Assurance Technician

SUMMARY: The QA Technician is responsible for ensuring that the assigned areas of the Quality Management System (QMS) are effectively controlled and in compliance to the requirements specified in OCC’s QMS, the relevant international standards and other applicable regulations. The QA Technician will be the primary contact/lead for Returned Materials Authorization (RMA), Corrective Action Request (CAR) processing, Preventative Action Request (PAR) processing, and to ensure OCC compliance to daily business practices, ISO requirements and other applicable standards.

Responsibilities: I. The Quality Technician will perform any of the following job responsibilities as assigned by the Quality Manager and as necessary to maintaining OCC’s QMS:

• RMA: Accurately conduct timely Failure Mode Analysis of nonconforming product returned through the RMA process. Coordinate and follow up for complaints and returned product.

• Corrective Action: Responsible for determining root cause of nonconformances, development and implementation of irreversible corrective actions and completion of the CAR form. These actions will be performed in a timely fashion and the results will be reported to management.

• Continuous Improvements: Initiation and implementation of Preventive Action Requests to facilitate continuous improvements in all aspects of the business.

• Calibration: Identification of all equipment that requires calibration, assigning equipment numbers, determining calibration frequency and ensuring calibration is completed on schedule.

• Inspection: Assist in visual and mechanical inspection of product at Incoming, In-process and Final quality inspections. This includes, but is not limited to, the use of measurement equipment such as micrometers, rulers and optical measurement equipment.

• Audits: Initiation, facilitation and completion of Internal Audits of the QMS.

• Nonconforming material: Ensure that nonconforming material is identified, controlled and dispositioned to prevent its unintended use or delivery.

• Data Analysis: Collect and evaluate data to determine compliance to goals for key process indicators.

• Work Instructions: Work with other departments to create, verify/validate, issue and maintain Standard Operating Procedures.

II. Promotes OCC’s service excellence and quality. Provides excellent service to customers; builds strong relationships and team cohesiveness; focuses on quality and positive solutions; communicates respectfully; demonstrates compassion and understanding in response to customer request/needs.

III. Champions OCC’s vision and values (as outlined in our 15 Essential Points of Success); complies with policies and procedures, ethical standards and Code of Conduct.

ESSENTIAL SKILLS, ABILITIES AND KNOWLEDGE:

I. Good computer skills (Word, Excel, ERP).

II. Compile, organization, and charting data for use by Management.

III. Ability to understand and implement quality procedures.

IV. Good math and handwriting skills required and the ability to correctly complete all paperwork.

V. Good oral, written, and interpersonal skills required with the ability to give direction, advice, and assistance to others.

VI. Ability to work in a team environment and assist in training, motivating, monitoring and evaluating others.

VII. Attention to detail with the ability to complete assignments accurately and to recognize, record and help solve problems.

VIII. Able to organize, complete tasks, and manage time.

IX. Ability to work with minimal supervision.

EDUCATION: Two (2) year associate degree in engineering or science and two (2) years quality or engineering experience preferred. Equivalent work experience may be substituted for education requirements – 2 years for every year of college.

Working Conditions: While performing this job, the employee is regularly required to stand and must be reasonably ambulatory. The employee must regularly lift and/or move up to 35 lbs. This job requires vision sufficient for completing quality work, reading comprehension and computer use. This work also requires hearing sufficient for normal workplace conversation and training. The noise level in the work environment is usually moderate. The employee is regularly exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. Reasonable accommodation may be made to enable individuals with a disability to perform the essential functions. Specific vison abilities required by this job include color vision.

Note: This job description is only meant to be a representative summary of the major responsibilities and accountabilities performed by incumbents of this job. The incumbents may be requested to perform job-related tasks other than those stated in this description.

Benefits: OCC offers a positive work environment driven around 15 Essential Points of Success, which is how OCC aspires to operate and is an integral part of our corporate philosophy and culture. OCC offers a competitive benefits package to promote health and financial security for you and your family that includes company-sponsored health, dental and vision plans, Health Savings Accounts (HSA’s), Flexible Spending Accounts (FSA’s), life insurance, short and long term disability coverage, optional supplemental insurance plans; including, critical illness and accident, a 401(k) plan, an Employee Assistance Program (EAP), education assistance, and wireless discounts. Employees are also provided with security options including Healthy Rewards®, Secure Travel®, Will Preparation and Identity Theft protection as well as generous paid time off and holiday schedules.

Optical Cable Corporation is an EEO/AA/Veterans/Disability Employer. For additional information, please  contact Deidra.sturgill@occfiber.com, or submit resume to:

http://www.occfiber.com/x_upload/news/files/AAP_website_link_0414.pdf. Connect with us… Facebook | Twitter | LinkedIn

www.occfiber.com

Deidra Sturgill Human Resources Representative, 

5290 Concourse Drive Roanoke, VA 24019

+1-540-795-4623 Phone +1-540-777-0561 Fax

QA Engineering Manager – Ft. Worth, TX – Elbit Systems of America

Elbit Systems of America is looking for an experienced Quality Assurance (QA) Engineering Manager in support of Operations based in Fort Worth, TX. The Quality professional will be responsible for the strategic leadership and performance of several key areas of responsibility, including overall program Quality business process management, data analytics, continuous improvement, talent development, training and knowledge continuity. The candidate will act as a Subject Matter Expert in the area of Quality Engineering and as an Adviser for the Quality team. This position requires that the candidate stay current with industry standards, solutions and leverage best practices. Duties include, but not limited to:

Drive strategies resulting in contemporary and optimal business methods and practices for strengthening the Quality Management System and talent development

Develop and implement processes to optimize program execution while driving out risks

Collaborate with Integrated Product Teams to ensure quality standards are in place

Lean design and implementation

Establish Program Quality Management System that comply with customer requirements and governmental regulatory standards

Establish performance metrics and conducting data analysis to identify process improvements

Liaison between program and the Customer to ensure Customer satisfaction and accomplishment of Customer requirements

Develop talent to strengthen the organization

Basic Qualifications:

Technical Engineering degree, or equivalent experience, in one of the following disciplines: Mechanical, Electrical, or Industrial Engineering

Experience working with both Mechanical and Electrical assemblies preferred

Implementation of Lean in both operations and business processes

Proficient with critical quality analysis and decision making – Stop Ship, Recalls, Root Cause Analysis

Advanced understanding of Quality principles in Aerospace industry

Experience managing the development, modification, application and maintenance of quality standards and protocol for processing materials into partially finished or finished materials product

Experience with control and disposition of non-conforming material

Effective presentation skills, ability to develop messages, training and compelling strategies resulting in diverse teams implementing and executing new solutions

Must be able to effectively communicate and interact with Technical Operations, Manufacturing, Global Supply Chain and all other stakeholders

Experience working with Government customers and DCMA

Experienced as a team lead and facilitator

Ability to influence outcomes and drive results

Must have the ability to travel

Desired Skills:

Experience with service-oriented depot repair and maintenance environment

Lean / Six Sigma Green or Black Belt Certification

ASQ Certified Quality Engineer (CQE) and / or Certified Quality Improvement Associate (CQIA)

Advanced understanding in AS9100 and ISO 9001 Quality Management Systems

Experienced in Bid, Proposal and Estimating practices and development of Quality Assurance Basis of Estimates (BOE)

Earned Value Management System Cost Account Manager (EVMS CAM)

Familiar with requirements for handling and control of Government Owned Property during field, ground or operational tests

Hiring Manager:               Mark Brown, Director of Quality

Contact Information:     mark.brown@elbitsystems-us.com

Quality Engineer – Ft. Worth – Elbit Systems of America

Quality Engineer

Elbit Systems of America is looking for an experienced Quality Assurance Engineer (QAE) to support Operations based in Fort Worth, TX.

Working in a collaborative team environment, interested candidates must exhibit initiative, and a strong desire to drive actions to successful completion.  In this role you will provide Quality Engineering support, guidance and instruction to inspectors, operators and other functional support of manufacturing, integration and test.  Typical support activities include root cause and corrective action, preventative action, adoption of best practices, metrics/data analysis, hardware disposition, first article inspection, customer satisfaction and other continuous improvement initiatives.

Required Skills & Education:

Bachelor Degree a minimum of 8 years of related work experience

Experience working with both Mechanical and Electrical assemblies

Familiarity with AS9100 and ISO 9001 Quality Management Systems

Strong communication skills (written, verbal, visual)

Proficiency applying root cause and corrective action (RCCA) tools

Proficient in use of computer software related quality tools

Experience conduction First Article Inspection (FAI) per AS9102

Supplier monitoring and issue resolution – Willingness to travel

Collaborate with Integrated Product Teams to ensure quality standards are in place

Monitor and report on assigned customer quality metrics in customer systems and database interfaces

Desired Skills & Education:

Experience with service-oriented depot repair and maintenance environment

Lean / Six Sigma Green or Black Belt Certification or equivalent statistical application and familiarity

ASQ Certified Quality Engineer (CQE) and / or Certified Quality Improvement Associate (CQIA)

Advanced understanding in AS9100 and ISO 9001 Quality Management Systems

Experienced in Bid, Proposal and Estimating practices and development of Quality Assurance Basis of Estimates (BOE)

Lean design, implementation and process optimization

Familiar with requirements for handling and control of Government Owned Property during field, ground or operational tests

Hiring Manager:               Mark Brown, Director of Quality

Contact Information:     mark.brown@elbitsystems-us.com

Operational Excellence Manager

HITACHI HIGH TECHNOLOGIES AMERICA, INC.

JOB DESCRIPTION

POSITION TITLE:         Operational Excellence Manager      

DEPARTMENT NAME:  Supply Chain Team

GENERAL DESCRIPTION

This Operational Excellence Manager will support the activities of the SED (Semiconductor Equipment Division) business divisions reporting to Director of Supply Chain Operations.  This position requires a self-motivated, intellectually curious team member with the ability to adapt to change in a fast moving environment.  General responsibility includes ISO certification activities, utilizing continual improvement methodologies such as Lean Six Sigma and Kaizen principles for improved internal operations, working with divisional leaders and team members to document processes, perform internal assessments, management reviews, and manage the corrective action process and activities for the departments.

RESPONSIBILITIES

  • Lead the development and execution of process improvements utilizing Operational Excellence methods
  • Develop and manage customer requirements, business processes, and key performance indicators aimed to improve products and services
  • Serve as a change agent, driving continual and sustainable improvement culture through consistent exhibition and initiation of Operational Excellence and Quality initiatives.
  • Development of local Operational Excellence program in alignment with the business unit/division the strategy.  Actively work with team to share best practices and implement it.
  • Monitor complex monthly process excellence performance metrics to ensure that organization objectives in the areas of cost, efficiency, and quality are met.
  • Facilitate meetings with management to review and examine project progress.
  • Lead division-wide improvement activities and cross functional teams in continual improvement activities with focus on supply chain operations, quality systems management
  • Work collaboratively with operational leadership and represented work groups to develop and implement sustainable solutions
  • Utilize various analytical and metric data to recognize areas for improvement.
  • Make use of lean enterprise concepts such as; DMAIC, Lean Six Sigma, and Kaizen principles to identify non-value added activities
  • Manage multiple projects, provide status updates on performance against plan and meet delivery targets
  • Lead GAP and root-cause analysis for departmental procedures and recommend resolutions
  • Develop and deliver training including training materials on the Quality Management System and process updates to all departments and different management levels
  • Develop training materials from projects and deliver the training to subject-matter-experts focusing on the gap closure areas and project specific highlights
  • Lead ISO certification activities
  • Collaborate with leaders and other team members in process documentation, assessments and reviews
  • Manage the Corrective Action Process
  • Customer point-of-contact and provide on-site, teleconference, and video support to OE team members.
  • Participate and provide additional support functions as assigned

SKILLS AND ABILITIES REQUIREMENTS

  • Must be able to communicate to all levels of staff members
  • Demonstrate strong project management skills
  • Must be able to transcribe informal conversations into formal business process documentation
  • Ability to write documents for long periods of time (repetitive process of creating documentation)
  • Ability to recognize gaps in documentation and processes and apply formal problem solving techniques to achieve resolution
  • Ability to identify root-causes and offer objective resolutions to all level of staffs
  • Must be able to work independently as well as in a team
  • Ability to execute and deliver results across a broad range of activities
  • Able to support our program and team needs in a global environment across the United States, Europe, and Japan

EDUCATION, LICENSES, AND/OR CERTIFICATION REQUIREMENTS

  • BA/BS degree in Supply Chain, Business, Engineering, or other technical discipline required
  • Master’s degree in Supply Chain, Business, Engineering, or other technical discipline desired
  • Certified Six Sigma Black Belt required, Master Black Belt desired
  • Attendance to current ISO9001-related course(s)
  • Active ASQ certification(s) a plus.

EXPERIENCE AND TRAVEL REQUIREMENTS

  • 3~ years of ISO experience, specifically ISO9001:2015.
  • 5~ years of Operational Excellence or relevant work experience
  • Excellent analytical, leadership, communication, planning, interpersonal, PC and organizational skills required
  • Proficient in Microsoft Office suites, Visio, SharePoint, Sales Force.
  • Statistical analysis and computer background required
  • 5~ years of management experience
  • Experience in delivering workshop/classroom training desired
  • Must be able to read, write, fluently speak, and understand the English language
  • Previous experience involved in ISO certification activities such as management representative, management review, internal auditing, corrective and preventive actions, etc. required
  • Able to travel domestically and occasionally internationally.

Equal Opportunity Employer: 

EOE – Females/Minorities/Protected Veterans/Individuals with Disabilities

To apply:

Visit our career site https://www.hitachi-hightech.com/us/about/careers/ and apply through the website.

ISO Business Process Analyst

HITACHI HIGH TECHNOLOGIES AMERICA, INC.

JOB DESCRIPTION

POSITION TITLE:         ISO Process Analyst    

DIVISION:                    Semiconductor Equipment Division (SED)

DEPARTMENT:            Supply Chain  

GENERAL DESCRIPTION

The ISO/Business Process Analyst will support the activities of the ISO Programs Group reporting to Operational Excellence Manager.  This interesting and challenging position requires a self-motivated, intellectually curious team member with the ability to adapt to change in a fast moving environment. General responsibility includes ISO certification activities, working with divisional leaders and team members to document processes, perform internal assessments, management review, and facilitate the corrective action process and activities for the departments.

RESPONSIBILITIES

  • Perform GAP and root-cause analysis for departmental procedures and recommend resolutions
  • Develop and deliver training including training materials on the Quality Management System and process updates to all departments and different management levels
  • Develop training materials from projects and deliver the training to subject-matter-experts focusing on the gap closure areas and project specific highlights
  • Participate in ISO certification activities – Schedule and maintain applicable ISO program activities
  • Collaborate with leaders and other team members in process documentation, assessments and reviews
  • Facilitate the Corrective Action Process
  • Work on various continual improvement projects for the division
  • Customer point-of-contact and provide on-site, teleconference, and video support to team members.
  • Participate in various departmental projects as needed
  • Additional support functions as assigned

SKILLS AND ABILITIES REQUIREMENTS

  • Must be able to communicate to all levels of staff members
  • Ability to manage multiple projects and priorities
  • Must be able to transcribe informal conversations into formal business process documentation
  • Ability to write documents for long periods of time (repetitive process of creating documentation)
  • Ability to recognize gaps in documentation and processes and apply formal problem solving techniques to achieve resolution
  • Ability to identify root-causes and offer objective resolutions to all level of staffs
  • Must be able to work independently as well as in a team
  • Ability to execute and deliver results across a broad range of activities
  • Able to support our program and team needs in a global environment across the United States, Europe, and Japan

EDUCATION, LICENSES, AND/OR CERTIFICATION REQUIREMENTS

  • BA degree in Supply Chain, Business, Quality, Engineer related required
  • 1-3 years of ISO related work experience
  • Attendance to current ISO9001-related course(s)
  • Active ASQ certification(s) a plus

EXPERIENCE AND TRAVEL REQUIREMENTS

  • 1-3 years ISO experience, specifically ISO9001:2015.
  • Beginning level writing documentation. Creating MS Word templates, forms, and utilizing macros a plus.
  • Proficient in Microsoft Office suites, Visio and SharePoint, Sales Force.
  • Previous experience involved in ISO certification activities such as management representative, management review, internal auditing, corrective and preventive actions, etc. a plus.
  • Experience creating process flow charts a plus.
  • Able to travel domestically and occasionally internationally.

Equal Opportunity Employer: 

EOE – Females/Minorities/Protected Veterans/Individuals with Disabilities

To apply:

Visit our career site https://www.hitachi-hightech.com/us/about/careers/ and apply through the website.

Quality Engineer, SQA Services

The Quality Engineer will be responsible for the execution of assigned activities for technical support and process validation related to new products, process, equipment, and troubleshooting of current processes associated with OTC & Cosmetic Sterile/Non-Sterile Liquids (Compounding, Filling, and Testing ) and Power Products (Blending, Capsule and Reservoir Filling of Devices). Interacts with production personnel, equipment engineering and QC Lab as well as provides some assistance and direction for less experienced engineering and technical personnel. Responsible for the execution and processing of product complaint investigations.

Execute assigned projects for the implementation of new processes, problem solving for existing processes, process optimization and process validation activities. Generate related documents including SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations. Develop and execute design of experiments (DoE) to support the development and registration of manufacturing processes used to produce clinical and commercial products. Provide technical and operational support to meet customer commitments (internal and external). Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing.

Requirements

Bachelor’s degree in chemical engineering or life sciences

5+ years’ relevant experience

Direct experience with MDI and Sterile/Non-Sterile Processes

Conduct DOE’s for process development and process improvement

Ability to statistically analyze data in support of technical and regulatory documents

Knowledgeable in cGMP’s and regulatory requirements

Familiar with the activity sequence for process investigations and/or Root Cause Analysis

Knowledgeable in principles of process validation and cGMP’s

If interested in this position please send your resume to Tami Parker at tparker@sqaservices.com, or call 310.802.4415

Process Engineer, SQA Services

Process Engineer

Compounding Processing Engineer is a critical technical role for the company and supports development, scale up and manufacturing of cosmetic and OTC batching. The incumbent will support our growth and have a strong focus on safety, quality and compliance. Responsible for all processes related to raw materials – incoming raw testing, storing, pre-weighing, compounding and filling as well as oversee different areas ensuring all SOPs and GMPs are followed and product meets general QC requirements.

Responsibilities:

  • Works in a specific area of operation (hot fill, high viscosity products, lip balm filling, powders or solids as examples).
  • Conducts analysis of current processes and determine/recommend optimal improvements.
  • Collects, compiles, and analyzes process data by capturing critical processing parameters and operating information for more data-based decision making, trending, and analysis
  • Creates short and long-term improvements that may be achieved through major capital investments or a series of smaller improvements or expansion projects.
  • Responsible for all products that come from R&D for scale-up.
  • Converts lab processes into fully commercial products, working closely with the R&D chemist to understand critical processing steps and phases, sensitivities to shear, temperature, and other conditions.
  • Supports Process Validation and Equipment Qualification activities
  • Writes manufacturing instructions, supervises pilot and 1st shift production, stabling final specifications and training manufacturing personnel.

Requirements:

  • Demonstrated comprehensive understanding of upstream processes such as pre-weight/cleaning and their impact.
  • Downstream processes and how to optimize the satisfaction of internal customers such as filling should be completely understood as well.
  • Successfully transfer newly developed formulations to manufacturing by converting lab processes and observations into practical, appropriate and scale-able production or processes.
  • Continuously improves previously release formulation processes that are or become problematic if batches are unable to be fully completed using the manufacturing instructions, require significant adjustments to get close to or do not have documentation indications specific equipment requirements.
  • Investigation and problem-solving tools are utilized to determine root cause and effective corrective actions.
  • BS Degree required, chemical science or chemical engineering strongly preferred
  • 3-7 years of compounding and filling process improvement experience in cosmetic and or pharmaceutical industries.
  • Technically strong in batch manufacturing operations, related batching equipment, and problem solving
  • Demonstrated ability to train and work with manufacturing personnel.
  • Capable of partnering with R&D, maintenance and quality personnel
  • Trained in cGMP requirements, including batch documentation and sanitization

If interested in this position, please contact Tami Parker at TParker@sqaservices.com or call 310-802-4415.

ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.

Career change in your future?

Our jobs posting service is back on-line and going strong. The format is a little different but easy to navigate.

If you are looking for a new position, click on the CAREER/Career Opportunities tab at the top of the home page, and check out all the new additions.These jobs are not only local, but throughout the US, looking for skills from food to biotech at many different job levels.

Joe Eudy from the Ft. Worth section is also busy posting resumes to our members who want more publicity.  If you have an opening you might want to read through the resumes of those who are already out there. If you would like your resume posted, just contact Joe through the page link and send him an email.  For faster response, please put “ASQ- RESUME POSTING” in the email posting and he will get to it asap.

Happy Hunting!