Coordinates with quality and engineering personnel to ensure compliance with internal policies and procedures as well as to applicable external standards (GMP, QSR, ISO 13485, etc.).
Performs quality review and approval of regulated documentation including, but not limited to, part/component/system inspection reports, nonconforming material reports, deviations, engineering change orders, engineering change reports, and engineering work orders.
Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
Responsible for adherence to supplier and customer Quality Agreement provisions.
Verifies, creates and/or revises SOPs, work instructions and associated forms, and participates in the implementation of these procedures.
Verifies engineering tests and measurement practices for new and existing products using appropriate tools.
Manages the CAPA, Complaints, Non-Conforming Material, Deviation systems; including generating Quality metrics.
Reviews drawings for adherence to design inputs, design control procedures, regulatory standards, and quality system requirements.
Provides quality oversight for product release and shipping activities. Reviews and approves Device History Records for finished device release as required.
Assist Quality Manager in creating and revising standard operating procedures, as needed.
Ensure employees follow procedures; perform ongoing gap analysis and work with managers to assign employee training.
Lead internal audits and participate in and support external customer/regulatory audits as needed.
Ensure quality and regulatory requirements are successfully implemented and maintained.
Present issues, trends, and feedback clearly at CAPA Meetings.
Actively track CAPA’s, as needed, and remain diligent to ensure the tasks are completed on time.
Identify and control manufacturing process defects (scrap, nonconforming material, custom complaints) by identifying the primary root causes and implementing corrective and preventative actions.
Experience/Skill/ Education:
Experience working with CAPA, Management Review, Change Control and Audit processes.
Working knowledge of 21CFR 820, and ISO 13485, AS9100 quality requirements and military specifications
Previous experience with effective root cause investigation, corrective and preventive action planning.
Experience with quality tools and process improvement techniques.
Experience reviewing technical documentation.
Strong written and verbal communication skills
Strong critical thinking and analytical skills
Ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
Bachelor’s Degree in electronics engineering preferred with 5+ years of experience in manufacturing, or equivalent combination of education, training, and relevant work experience may be considered.
Working knowledge of IPC-A-610, J-STD-001
Experience in the Medical Device Industry preferred
Experience/Skill/ Education:
Experience working with CAPA, Management Review, Change Control and Audit processes.
Working knowledge of 21CFR 820, and ISO 13485, AS9100 quality requirements and military specifications
Previous experience with effective root cause investigation, corrective and preventive action planning.
Experience with quality tools and process improvement techniques.
Experience reviewing technical documentation.
Strong written and verbal communication skills
Strong critical thinking and analytical skills
Ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
Bachelor’s Degree in electronics engineering preferred with 5+ years of experience in manufacturing, or equivalent combination of education, training, and relevant work experience may be considered.
Working knowledge of IPC-A-610, J-STD-001
Experience in the Medical Device Industry preferred
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establish the drying kinetics of fresh and frozen breadfruit under several combinations of pretreatment(s) and drying methods and parameters while measuring the specific energy consumption (SEC),
analyze products for nutritional quality,
evaluate products for sensory quality, and
disseminate research findings in peer-reviewed journals and through stakeholder networks.
This position also has the opportunities to be involved in our collaborative projects working with food technologists, entomologists, (micro)biologists, plant pathologists, etc. within the Center, as well as other ARS locations, universities, and our industry partners and stakeholders.
To apply, and if any questions regarding the position, contact Dr. Peishih Liang ( Peishih.liang@usda.gov ).
U.S. citizenship or permanent residence is required.
The successful candidate will be hired at General Schedule (GS) grade 11. Please see OPM website for the salary table: https://www.opm.gov/policy-data-oversight/pay-leave/pay-systems/general-schedule/ Experience in food processing, Design of Experiments/statistics is required. Food science/technology background is preferred. Experience in machine learning/AI is preferred. Ph.D. in Agricultural and Biological Engineering, Food Science/Technology, or relevant fields is required. The successful candidate will be hired at General Schedule (GS) grade 11. Please see OPM website for the salary table: https://www.opm.gov/policy-data-oversight/pay-leave/pay-systems/general-schedule/