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Senior Design Quality Engineer
Job in
Rochester, Monroe County, New York, 14626, USA
Listed on 2026-06-06
Listing for:
inSync Staffing
Full Time
position Listed on 2026-06-06
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Duration: 1 year+
Summary
Senior Quality Engineer responsible for Design Controls, Risk Management, and Quality Systems compliance across hardware, software, and integrated IVD products. Partners with cross-functional teams to ensure product development activities meet global regulatory requirements, including ISO 13485, FDA 21 CFR 820, and IVDR. Supports validation, design changes, inspections, audits, and continuous improvement initiatives.
Key Responsibilities
- Support Design Controls, Risk Management, and product lifecycle Quality activities.
- Ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and related regulations.
- Partner with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams.
- Lead Quality support for design changes, validation strategies, and claim verification.
- Drive QMS improvements, process standardization, and inspection readiness.
- Represent Quality during audits and regulatory inspections.
- Provide technical guidance and mentorship to project teams.
- Communicate quality risks, recommendations, and project status to stakeholders.
- Bachelor's degree in Engineering, Life Sciences, or related field.
- 5+ years of Quality, Compliance, Medical Device, IVD, or Biopharmaceutical industry experience.
- Strong knowledge of Design Controls, Risk Management, ISO 13485, FDA 21 CFR 820, and IVDR.
- Excellent communication, collaboration, analytical, and problem-solving skills.
- Advanced degree (MS, PhD, MBA).
- Lean Six Sigma, PMP, or similar certification.
- Experience with QMS optimization, digital Quality tools, and regulatory inspections.
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#IND
0626
Position Requirements
10+ Years
work experience
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