Job Description
Senior Design Quality Engineer inSync Staffing - 4.0 Rochester, NY Job Details $55 - $65 an hour 1 day ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Vision insurance Life insurance Retirement plan Qualifications Quality management standards in production Quality risk management Design controls Biomedical regulatory compliance
ISO 13485 FDA
regulations Full Job Description Pay Rate:
$ 55.00-65.00/hr 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. Requirements 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. Preferred Advanced degree (MS, PhD, MBA). Lean Six Sigma, PMP, or similar certification. Experience with QMS optimization, digital Quality tools, and regulatory inspections. Benefits (employee contribution): 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. #IND0626
