Quality Engineer III
1 Millennium Way Branchburg, NJ 008876 US
**salary will be commensurate with experience**
The Quality Engineer III, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing support on applicable design control, human factors/usability engineering, and risk management processes. This position will lead product risk assessment efforts, including development of quality plans for risk analysis, development of risk controls, their implementation and verification of effectiveness, as well as lifecycle risk management planning.
Represent the Quality function on product and process development project teams. Actively support and engage in design reviews.
Lead or support design activities including design verification, validation, specification setting and justification, test method development, usability engineering, and risk management.
Evaluate protocols and reports to ensure that the testing is sufficient to meet regulatory requirements (e.g. ISO 10993, 13485, 22442, 62366) and quality objectives.
Generate or apply statistical methods with appropriate risk-based justification.
Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and verified.
Promote continuous improvement in design control activities and use of quality tools with design team.
Define critical to quality characteristics and inspection plans for components, subassemblies, and finished devices.
Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
Maintain expertise in both current and emerging requirements and quality trends as they relate to medical device and combination products worldwide.
Provide Risk Management support to quality subsystems of Health Hazard
Evaluation/Health Risk Assessment process, Risk Management Review, Quality System Management Review, and Post Market Surveillance.
Act as Risk Management subject matter expert (SME); provide guidance on impact to existing risk assessments due to change control and quality system improvements.
4+ years’ experience working in the Medical Device or Medical Device Combination product industry
Minimum of a BS in Engineering or Scientific discipline; MS preferred
Experience in Medical Device design and development activities; core team member role preferred
Experience leading product risk analysis and management throughout development lifecycle
Experience with injection molding and assembly preferred
Experience with animal and human tissues (HCT/Ps) regulation is a plus
Familiar with reliability analysis and test methods and test method validation
Familiar with process validation principles, including sub-tasks of equipment IQ, OQ, PQ
Strong verbal (including presentation) and written communication skills, especially technical report writing
Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, MDR, ISO 22442 Animal Tissues, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
Ability to effectively influence others without direct authority and partner with internal and external customers
Experience interacting with regulatory agencies and notified bodies; front room audit experience is a plus
Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA, DOE and other key tools for managing quality performance
*CO candidates may not be considered
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