Senior Quality Assurance Engineer

What you'll do

• Drive manufacturing and product lifecycle quality using risk-based approaches to ensure compliance with 21 CFR 820 and ISO 13485 standards.
• Manage New Product Introduction (NPI) and Change Control processes to ensure accurate deliverables during design transfer to manufacturing.
• Review change orders and deviations to confirm documented rationales and comprehensive impact assessments for significant modifications.
• Develop robust qualification strategies to mitigate risks associated with design and process changes while enhancing product reliability.
• Provide quality engineering oversight for medical device manufacturing, including plastic part design, equipment performance, and inspections.
• Lead risk assessment activities such as safety, design, and process FMEA to guide verification and validation planning.
• Create and review project documentation including validation master plans, IQ/OQ/PQ protocols, and quality control plans.
• Resolve nonconformities by performing root cause analysis and implementing corrective and preventive actions (CAPA).

What we're looking for

• A BS degree in mechanical, industrial, biomedical engineering, or a related field is required.
• A master's degree with at least 3 years of quality experience is an acceptable educational alternative.
• Candidates with a BS degree must have at least 5 years of quality engineering experience.
• Strong understanding of ISO 13485, 21 CFR 820, and GMP requirements is required.
• Proven experience in New Product Introduction (NPI) Quality and working with complex systems is required.
• Experience in design verification and validation, part and process qualification, and automation equipment qualification is required.
• Ability to travel domestically and internationally for up to 10% of the time is required.
• Certified Quality Engineer or Lead Auditor certifications are preferred qualifications.