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.

Senior Quality Representative

This position requires a minimum of 7 years of experience or equivalent education. Additional quality training certifications are a plus.

The position’s responsibilities include, but are not limited to the following: Acts as a lead in monitoring the Contractor’s quality program.

Ensures compliance with established processes and procedures.

Conducts training to project/construction management staff. Implements quality processes and procedures.

Monitors, and directs, the project/construction management quality staff.

Assists with the start-up and close-out of projects from a quality perspective.

Attend and participate in meetings, including internal and Contractor quality meetings. Other duties as assigned.

Interested parties should submit their resume to either Sondra Barlow: sbarlow@apmtexas.com or Shara Mandujano: smandujano@apmtexas.com

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

Cleaning Validation Engineer, SQA Services

The Cleaning Validation Engineer – OTC Drug and Device Products (CVE) shall generate and execute cleaning validation protocols for the facility (walls, floors, racks, etc.) and equipment (production and ancillary).  Cleaning validation protocols shall address requirements for control of all OTC Drug and Device Products (30 to 50 formulations), including assessment of impact/risk to product manufacturing processes and patient safety.  Prior to execution of cleaning validation protocols, the CVE shall ensure that adequate and validated test methods are in place for verification of cleaning.  As appropriate, test method validation shall be conducted in collaboration with an analytical chemist.

After completion of cleaning validation activities, the EVE shall generate cleaning validation reports for the facility (walls, floors, racks, etc.) and equipment (production and ancillary).  Cleaning validation reports shall address requirements for control of all OTC Drug and Device Products (30 to 50 formulations).  As required, the CVE shall provide procedure(s) relating to the requirements for ongoing qualification/requalification of cleaning for the facility and finished products, including assessment of impact/risk to product manufacturing processes and patient safety.

Essential Duties and Responsibilities

  • Assures that cleaning validation protocols and reports comply with United States Food & Drug Administration, Health Canada, ISO, and alternate regulatory and/or notified body requirements per client request.
  • Ensures target dates associated with completion of cleaning validation protocols and reports, and procedure updates are met.
  • Responds to comments/inquiries provided by SQA management and client with respect to in process cleaning validation protocols/reports and procedures and executes revisions, as required.
  • Responsible for following all SQA requirements related to travel arrangements, submission of work/travel hours, and expense report management.
  • Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings (as appropriate).


Qualifications Education and/or Experience

  • A Bachelor of Science or an advanced degree in a related field of study and 10 or more years of related experience and training.
  • Experience interacting with United States Food & Drug Administration and alternate regulatory and/or notified bodies as required.
  • Knowledge and skills associated with generation and execution of cleaning validation protocols/reports and procedure generation/revision.
  • Experience leading cleaning validation activities is required in collaboration with an analytical chemist and/or designated support staff.
  • Understanding of Data Integrity requirements.
  • Experience with and understanding of the following regulations and standards: 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, ICH Q9, ICH Q10.

Other Skills and Abilities

  • Ability to read, analyze and interpret applicable guidances, regulations and standards.
  • Ability to respond to complex inquiries from SQA management or clients. Ability to effectively present information to SQA management or clients.

If interested in this position, please send your resume to Tami Parker at tparker@sqaservices.com, or call 310-802-4415.

Utilities Validation Engineer, SQA Services

The Utilities Validation Engineer – OTC Drug and Device Products (UVE) shall generate and execute validation protocols for all facility utilities, including the water system and compressed air.  Validation protocols shall address initial (1 month duration) and 6 month (biannual requalification) time points. 

After completion of facility utility initial (1 month) validation activities, the UVE shall generate validation reports for each impacted utility, including the water system and compressed air.  As required, the UVE shall provide procedure(s) relating to the requirements for ongoing qualification/requalification of utilities (including 6 month biannual requalification).

Essential Duties and Responsibilities

  • Assures that utility validation protocols and reports comply with United States Food & Drug Administration, Health Canada, ISO, and alternate regulatory and/or notified body requirements per client request.
  • Ensures target dates associated with completion of the utility validation protocols and reports, and procedure updates are met.
  • Responds to comments/inquiries provided by SQA management and client with respect to in process utility validation protocols/reports and procedures and executes revisions, as required.
  • Responsible for following all SQA requirements related to travel arrangements, submission of work/travel hours, and expense report management.
  • Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings (as appropriate).


Qualifications Education and/or Experience

  • A Bachelor of Science or an advanced degree in a related field of study and 10 or more years of related experience and training.
  • Experience interacting with United States Food & Drug Administration and alternate regulatory and/or notified bodies as required.
  • Knowledge and skills associated with generation and execution of utility validation protocols/reports and procedure generation/revision.
  • Experience leading utility validation activities is required.
  • Understanding of Data Integrity requirements.
  • Experience with and understanding of the following regulations and standards: 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, ICH Q9, ICH Q10.

Other Skills and Abilities

  • Ability to read, analyze and interpret applicable guidances, regulations and standards.
  • Ability to respond to complex inquiries from SQA management or clients. Ability to effectively present information to SQA management or clients.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to use PC’s and associated Microsoft software.
  • Balanced technical understanding of products and processes combined with superior business and compliance acumen.
  • Accountability, with a strong desire to commit, be held accountable and deliver results.

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.

Process Validation Engineer – SQA Services, Inc.

The Process Validation Engineer – OTC Drug and Device Products (PVE) shall provide a facility Validation Master Plan to address requirements for roles and responsibilities, facility overview and design, general validation and qualification approach, facility Heating, Air Conditioning, and Ventilation (HVAC), utilities (including the water system and compressed air), manufacturing and laboratory equipment, computer systems (basic overview), products and manufacturing processes, cleaning, and analytical methods.  A Quality Systems approach shall be applied to the Validation Master Plan to ensure the above requirements are addressed for all manufactured products (OTC drug and device).

Based on the requirements specified in the facility Validation Master Plan, the PVE shall generate and execute Process Qualification protocols for all OTC drug and device products (30 to 50 formulations), applying a matrix approach.  In support of Process Qualification, the PVE shall update batch records for all OTC drug and device products to reflect current requirements for monitoring critical process variables.  Updated batch records shall be utilized for Process Qualification activities.  After completion of Process Qualification activities, the PVE shall generate Process Qualification reports for all OTC drug and device products.  As required, the PVE shall also update facility procedures relating to the requirements for ongoing qualification/requalification of OTC drug and device products.

Essential Duties and Responsibilities

  • Ensures that the facility Validation Master Plan, Process Qualification Protocols/Reports comply with United States Food & Drug Administration, Health Canada, ISO, and alternate regulatory and/or notified body requirements per client request.
  • Ensures target dates associated with completion of the Validation Master Plan, Process Qualification Protocols/Reports, batch records, and procedure updates are met.
  • Responds to comments/inquiries provided by SQA management and client with respect to in process Validation Master Plan, Process Qualification Protocols and Reports, batch records and procedures and executes revisions, as required.
  • Responsible for following all SQA requirements related to travel arrangements, submission of work/travel hours, and expense report management.
  • Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings (as appropriate).


Qualifications Education and/or Experience

  • A Bachelor of Science or an advanced degree in a related field of study and 10 or more years of related experience and training.
  • Experience interacting with United States Food & Drug Administration and alternate regulatory and/or notified bodies as required.
  • Knowledge and skills associated with generation and execution of Validation Master Plans, Process Qualification, batch record generation and execution, and procedure generation/revision.
  • Experience leading Process Qualification activities is required.
  • Understanding of Data Integrity and Computer System Validation requirements.
  • Experience with and understanding of the following regulations and standards: 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, ICH Q9, and ICH Q10.

Other Skills and Abilities

  • Ability to read, analyze and interpret applicable guidances, regulations and standards.
  • Ability to respond to complex inquiries from SQA management or clients. Ability to effectively present information to SQA management or clients.

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

Manager, Customer Feedback – Argon Medical – Athens, TX

Summary Description of this Job: Directs the planning, preparation and facilitates the timely submissions of all MDR, Vigilance and other regulatory reports to the appropriate regulatory authorities globally. Guides regulatory reporting activities globally, provides clinical expertise for PMS related activities. Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction. This position will hire staff, and conduct performance reviews and fulfill other management responsibilities. Successful candidate will have proven organizational skills with track record of achieving positive results.

Essential Duties and Responsibilities:

  • Communicates with customers to establish a full understanding of alleged adverse events.
  • Analyzes medical device reporting data to identify trends. Notifies designated internal personnel with appropriate findings and
    recommendations. Enables rapid and effective escalation and investigation of potential safety related issues.
  • Responsible for leading the Product Experience analysts’ team, manages workflow and processes. Supports the Product Experience Group in leading and directing the global process activities
  • Trains direct reports to ensure proper implementation and use of quality tools and procedures as required.
  • Manages complaint workflow and the processing of complaints within software applications
  • Interacts with Regulatory Authorities to answer follow-up questions, provide investigation details
  • Provides guidance on clinical risks and outcomes associated with medical device malfunctions
  • Assist or lead general compliance activities as required.
  • Other duties as assigned

Requirements:

Education/Degree:
Bachelor’s Degree in science, math or engineering discipline.   General knowledge of basic physiology, high level of research, analytical and problem solving skills; ability to prioritize for maximum results (multitask management)

Qualifications:

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. General knowledge of basic human physiology.

Demonstrated interpersonal skills to successfully partner with individuals to build relationships with business contacts, customers and regulatory entities.  Demonstrated capability to direct employees working with cross-functional teams to resolve customer issues *

Capability to train reports on QSR, Medical Device Directive, and ISO Quality System Standards. EU MDR understanding is a plus. Proven excellent analytical, decision making, and problem-solving skills to successfully define problems, collect data, establish facts and draw accurate conclusions, and to train and manage direct reports to do the same.

Licensing/Certificates:
CQA or CBA or RABSQA required. CQE and CQMgr/OE certifications preferred.

Computer Skills:

Minitab software or similar statistical analysis software tool; General Microsoft Office applications. Work experience with electronic QMS software.

Experience:

Minimum 7 – 10 years of work experience in regulated healthcare environment (ISO 13485:2016 and 21 CFR 820); past participation in Notified Body and FDA audits. Strong knowledge of applicable standards and guidance documents; ability to lead and mentor in a team environment.

If interested in this position, please send copy of your resume and contact information to Kelsey George at the following address: Kelsey.George@argonmedical.com.