Quality Engineer III

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
• CQE preferred

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.