QA/Inventory/Shipping and Receiving Clerk – Crown Technical Systems – Garland, TX 75040

Crown Technical Systems is a rapidly expanding company in the ever growing electrical power industry.  Our main facility is located in Fontana, CA; we have a facility in the City of Vaughn, Ontario, Canada and Garland, Texas. We are a leader in the design and manufacturing of arc-resistant and non-arc, medium voltage metal clad switchgear, control buildings and enclosures, protective relay panels and more.  We are looking for experienced and dedicated individuals with the desire to take on new challenges, assist in developing our product lines and grow with our company.  We are offering stability, growth potential, competitive wages, and the chance to be a part of exciting new and cutting edge projects that adds to the power infrastructure of America and Canada with concurrent benefit to communities across both countries.

Address: 2350 Crist Road Suite 1300, Garland, TX 75040

1st shift hours:

Monday through Friday: 6:00 am-2:45 pm

(Subject to change at company’s discretion)

Responsibilities will include but not limited to:

  • Inspects incoming materials by confirming product meets drawings and specifications; conducting visual and measurement tests; documenting and communicating rejections of unacceptable items.
  • Inspects in-process production by confirming product meets applicable drawings and specifications; conducting visual and measurement tests; documenting and communicating required corrections.
  • Inspects finished products by confirming product meets drawings and specifications; conducting visual and measurement tests; documenting and communicating required corrections and ensuring defective product is not delivered to the customer.
  • Documents inspection results by completing inspection reports and checklists; documenting corrective action requests; inputting data into corrective action database.
  • Keeps inspection and measurement equipment operating by following operating instructions; and notifying management when repairs are necessary.
  • Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.

Required:

  • ·Minimum of two years Quality Assurance Inspection experience in a fabrication/manufacturing environment.
  • Experience in Switchgear, Relay Panel, or Control Build manufacturing is a major plus.
  • Ability to work well with others and maintain a professional environment.
  • Good written and oral communication skills required.
  • Ability to handle multiple projects while maintaining attention to detail with the task at hand.
  • Experience with Microsoft Word, Excel, and Outlook is a must. Experience with AutoCad is a plus.

If interested in this position, please contact Heather Villarreal, Senior Human Resources Assistant, at

2350 Crist Road, Suite 1300, Garland, TX 75040 or email hvillarreal@crowntexas.com

Senior Quality Engineer – Lockheed Martin – Grand Prairie, TX

Apply Now for 501202BR

Contact Ebonee Gocha’, Quality Engineering Manager, 972-603-9836, ebonee.gocha@lmco.com

Description

Lockheed Martin is seeking a motivated and driven Senior Quality Engineer to support the PAC-3 Evolutionary Development and Transition to Production programs predominately on Flight Test Support.

The position requires previous quality engineering experience in developing and reviewing quality standards, methods, work instructions and procedures for the development of manufactured and procured products. Individual should be a self-starter who can work autonomously with minimal direction in a fast-paced dynamic environment. Must work well in a team environment, have excellent customer interface and presentation skills, have effective interpersonal skills and be able to work effectively. This role will be responsible in leading end item log book reviews with the customer to determine flight worthiness as well as participating in flight tests as the lead quality representative. Previous program office / customer interaction is highly desired.

Quality Engineers at Lockheed Martin Missiles and Fire Control act as an integrated member of the design and production teams developing and reviewing quality standards, methods, work instructions and procedures for the inspection of manufactured and procured products. In a culture of continuous improvement our department utilizes lean initiatives to reduce waste and drive affordability and efficiency. Working with an integrated team, which includes customer, suppliers and other functional personnel, non-conformances are identified, trended and resolved in a timely manner.


Candidates should be able to solve complex challenges and deliver innovative solutions that provide the best product for our customers, both domestically and internationally. The role also requires evaluating designs, both electrical and mechanical, to ensure a producible product is being proposed with processes in place for a smooth production flow.

Basic Qualifications

  • Technical Engineering degree from an accredited college in one of the following disciplines: Aerospace, Mechanical, Electrical, or Industrial Engineering or waive degree requirement with equivalent Engineering experience
  • Must have ability to obtain and maintain a security clearance
  • Previous quality engineering experience in developing and reviewing quality standards, methods, work instructions and procedures for the development of manufactured and procured products
  • Demonstrated understanding of audit techniques
  • Thorough understanding of engineering requirements and inspection methods
  • Ability to interpret drawings and specifications
  • Experience with control and disposition of non-conforming Material (Material Review Board)
  • Experience solving complex problems associated with the quality of products and in Quality Management processes / capable of performing root cause analysis and identifying solutions to complex problems
  • Experience working with Government customers
  • Proficient skill level with Microsoft Office applications: Word, Excel, PowerPoint, etc.
  • Effective communication skills (both written and verbal)
  • Must be able to effectively communicate and interact with Technical Operations, Manufacturing, and all other stakeholders
  • Demonstrated presentation skills
  • Ability to travel

Desired Skills

  • Electrical Engineering Degree
  • ASQ Certified Quality Engineer (CQE)) and / or Certified Quality Improvement Associate (CQIA)
  • Lean Six Sigma Green or Black Belt Certification
  • Effective interpersonal skills, including team building and collaboration
  • SAP/ERP experience
  • Strong familiarity with Production Operations
  • Experience with Program Office / Customer Interaction preferably DOD
  • A strong understanding of Geometric Dimensioning and Tolerancing (GD&T)
  • Experience with performing First Article Inspections to AS9102 requirements
  • Experience with source inspection and surveillance activities at suppliers (including acceptance of product / testing)
  • Thorough understanding in AS9100 and ISO 9001 Quality Management Systems as well as AS9145 Advanced Product Quality Planning
  • Experience with use of inspection gages and measuring equipment
  • Earned Value Management System Cost Account Manager (EVMS CAM) certification
  • Familiar with requirements for handling and control of Government Furnished Equipment / Property during field, ground or operational tests

Experience Level: Experienced Professional

Business Unit: ESS0385 MISSILES AND FIRE CONTROL

Relocation Available: POSSIBLE

Career Area: QA/Test and Inspection

Clearance Level: SECRET

Type: FULL TIME

Work Schedule: FLEX 9x80A – Friday off in 2nd week w flex hrs/day

Shift: FIRST

Quality Engineer – Lockheed Martin – Grand Prairie, TX

Apply Now for 501538BR;

Apply Now for 486809BR;

Apply Now for 485934BR

Contact

Ebonee Gocha’, Quality Engineering Manager, 972-603-9836 or email resume to ebonee.gocha@lmco.com

Description

Lockheed Martin is seeking a motivated and driven Senior Quality Engineer to support the PAC-3 Evolutionary Development and Transition to Production programs.


Individual should be a self-starter who can work autonomously with minimal direction in a fast-paced dynamic environment. You will collaborate with Engineering, Manufacturing, Subcontracting, Program Management, suppliers, and customer to ensure quality standards are implemented and being met throughout the product development process. Role will require monitoring performance of suppliers (internal & external), providing support for root cause and corrective/preventative actions, supporting supplier requests tied to program requirements, participating in Material Review Board (MRB) activities, providing technical liaison support related to quality engineering matters, auditing program and suppliers for conformance to requirements, and working closely with the Customer to ensure adequate acceptance of product.

The position requires previous quality engineering experience in developing and reviewing quality standards, methods, work instructions and procedures for the development of manufactured and procured products. The role also requires evaluating designs, both electrical and mechanical, to ensure a producible product is being proposed with processes in place for a smooth production flow.


Candidates should be able to solve complex challenges and deliver innovative solutions that provide the best product for our customers, both domestically and internationally.

Basic Qualifications

  • Technical Engineering degree from an accredited college in one of the following disciplines: Aerospace, Mechanical, Electrical, or Industrial Engineering or waive degree requirement with equivalent Engineering experience
  • Must have ability to obtain and maintain a security clearance
  • Previous quality engineering experience in developing and reviewing quality standards, methods, work instructions and procedures for the development of manufactured and procured products
  • Demonstrated understanding of audit techniques
  • Thorough understanding of engineering requirements and inspection methods
  • Ability to interpret drawings and specifications
  • Experience with control and disposition of non-conforming Material (Material Review Board)
  • Experience solving complex problems associated with the quality of products and in Quality Management processes / capable of performing root cause analysis and identifying solutions to complex problems
  • Experience working with Government customers
  • Proficient skill level with Microsoft Office applications: Word, Excel, PowerPoint, etc.
  • Effective communication skills (both written and verbal)
  • Must be able to effectively communicate and interact with Technical Operations, Manufacturing, and all other stakeholders
  • Demonstrated presentation skills
  • Ability to travel

Desired Skills

  • Electrical Engineering Degree
  • ASQ Certified Quality Engineer (CQE)) and / or Certified Quality Improvement Associate (CQIA)
  • Lean Six Sigma Green or Black Belt Certification
  • Effective interpersonal skills, including team building and collaboration
  • SAP/ERP experience
  • Strong familiarity with Production Operations
  • Experience with Program Office / Customer Interaction preferably DOD
  • A strong understanding of Geometric Dimensioning and Tolerancing (GD&T)
  • Experience with performing First Article Inspections to AS9102 requirements
  • Experience with source inspection and surveillance activities at suppliers (including acceptance of product / testing)
  • Thorough understanding in AS9100 and ISO 9001 Quality Management Systems as well as AS9145 Advanced Product Quality Planning
  • Experience with use of inspection gages and measuring equipment
  • Earned Value Management System Cost Account Manager (EVMS CAM) certification
  • Familiar with requirements for handling and control of Government Furnished Equipment / Property during field, ground or operational tests
  • Experience Level: Experienced Professional
  • Business Unit: ESS0385 MISSILES AND FIRE CONTROL
  • Relocation Available: POSSIBLE
  • Career Area: QA/Test and Inspection
  • Clearance Level: SECRET
  • Type: FULL TIME
  • Work Schedule: FLEX 9x80A – Friday off in 2nd week w flex hrs/day
  • Shift: FIRST

Senior RA Specialist – Frisco, TX – Argon Medical Devices

Authors regulatory submissions and technical files in both US and OUS markets.  Organizes regulatory information and tracks and controls submissions. Participates in new product development teams.  Reviews and advises on labeling for compliance with regulatory filings.  Reviews product changes for impact on regulatory filings worldwide. Researches regulatory issues and provides guidance and advice to colleagues.  Participates in company regulatory compliance.

Essential Duties and Responsibilities:

Provide regulatory guidance to colleagues to ensure subsequent documentation will meet the needs of the regulatory submissions

Prepare US 510(k)/Letter to File, create Technical Documentation for EU and other STED formats for global registrations

Prepare and submit OUS license applications

Maintain regulatory files/database and chronologies in good order.  Establish and maintain system for tracking changes in documents submitted to agencies or partners

Review labeling and labels for compliance with regulatory requirements

Review changes to existing products and SOPs to define the requirements for regulatory submissions

Other duties as assigned.

EDUCATION/TRAINING/EXPERIENCE

Establish and monitor procedures to ensure high quality of work; develops and organizes systems to track data and work progress; develops and uses systems to organize and keep track of information or work progress; organizes information or materials for others. Carefully reviews and checks the accuracy of information in work reports (e.g., production, sales, financial performance) provided by management, management information systems, or other individuals and groups. Must be a self-starter and possess the ability to work with minimal supervision.

Bachelor’s degree in science, math or engineering discipline required. 5+ years relevant experience in FDA regulatory industry – US Class II products and higher. Previous experience in global registrations, including experience with MDD and MDR preferred.

Must have excellent communication skills, ability to manage multiple priorities, creative problem solving ability; excellent oral and written presentation skills, team-oriented; good planning and organizational skills; strong critical thinking ability.

RAC preferred. Previous audit training/certification preferred.

Expertise with MS Office, including Excel, Word, Access, Project and Visio.

If interested in this position, please send your resume to Amy Wheeler, Regulatory Affairs Manager, at Amy.Wheeler@argonmedical.com.

Senior Quality Engineer- Adverse Event Reporting – Frisco, TX – Argon Medical Devices, Inc.

This position is responsible for developing and maintaining quality engineering methodologies to ensure regulatory compliance. Prepares and facilitates the timely submissions of all MDR, Vigilance and other regulatory reports to the appropriate regulatory authorities globally. Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction. Works with various department teams to conduct timely and accurate Health Hazard Evaluations (HHE) and communicate need for field corrective action if warranted.

*Analyze medical device reporting data to identify trends and notify designated internal personnel with the findings and recommendations. Enable rapid and effective escalation and investigation of potential safety related issues

Interact with Regulatory Authorities to answer follow-up questions and provide investigation details.

Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

Assist or lead general compliance activities as required. Other duties as assigned.

Establish and monitor procedures to ensure high quality of work; develops and organizes systems to track data and work progress; develops and uses systems to organize and keep track of information or work progress; organizes information or materials for others. Carefully reviews and checks the accuracy of information in work reports (e.g., production, sales, financial performance) provided by management, management information systems, or other individuals and groups. Must be a self-starter and possess the ability to work with minimal supervision.

Approaches challenging tasks with a “can-do” attitude; effectively handle several problems or tasks at once; maintains a sense of humor under difficult circumstances; demonstrates openness to new organizational structures, procedures. 

EDUCATION/TRAINING/EXPERIENCE

BS degree plus 1 – 2 years as a Quality Engineer. 5-7 years of work experience in regulated healthcare environment (ISO 13485:2016/21 CFR 820). Previous experience in writing US MDRs for FDA and Adverse Event reporting required. CQE or CQA preferred. Strong skills in Microsoft office. Previous experience with electronic QMS preferred.

If interested please email resume to Brian Rogers, Director of Post- Market Experience at Brian.Rogers@argonmedical.com

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.