Design Quality Engineer
Rochester, New York, United States of America
Full Time
3 weeks ago
$102,000 - $133,000 USD
No Visa Sponsorship
Key skills
RLeadershipCommunicationCollaboration
About this role
Role Overview
- Support complex Quality engineering activities that support business and compliance priorities, ensuring timely delivery and high technical rigor.
- Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards.
- Support the harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen consistency and efficiency.
- Collaborate closely with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
- Drive continuous improvement initiatives, identifying opportunities for simplification, process optimization, and digital enablement within the Quality Management System (QMS).
- Support a high level of inspection readiness and serve as a Quality representative during regulatory agency inspections, notified body audits, and internal audits.
- Provide coaching and technical guidance to peers, junior engineers, and project teams to strengthen organizational Quality and scientific capability.
- Communicate Quality-related risks, recommendations, and progress to project teams, cross-functional partners, and Quality leadership.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- 5+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays