Senior Quality Engineer, Medical Device

Quality & Regulatory Talent for Medical Device + Pharma | Direct Hire

West Leland Group is partnering with an established medical device company to hire a Senior Quality Engineer with deep experience in Design Controls and Product Development support. This role plays a critical part in ensuring that design requirements,
verification and validation (V&V) activities,
risk management
, and design documentation are structured, compliant, and aligned with active product development initiatives.

The ideal candidate is a technically strong engineer who enjoys partnering closely with R&D and driving high-quality design outcomes across mechanical, electrical, and software product areas.

• Lead key Design Controls activities throughout new product development and design changes.
• Update and maintain Design History Files (DHF),
  Device Master Records (DMR), and associated design documentation.
• Partner with R&D to ensure user needs
  , design inputs
  , and design outputs are defined, traceable, and fully compliant.
• Develop, review, and support the execution of Design Verification & Validation (V&V) protocols and reports.
• Host and facilitate formal Design Reviews with cross‑functional teams.
• Drive product risk management activities including FMEAs, risk file updates, and mitigation strategies.
• Support supplier quality efforts including audits, nonconformance reviews, and corrective action follow‑up.
• Analyze data across complaints, nonconformances, and supplier performance to identify trends and improvement opportunities.
• Collaborate closely with mechanical, electrical, software, and manufacturing engineering teams.
• Work through a backlog of design‑related quality tasks to bring documentation and controls up to current standards.
• Support broader quality system needs such as CAPA
  , document control, validation support, and calibration oversight.

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related).
• 5–10+ years of Quality Engineering experience in medical devices
  , with strong involvement in Design Controls and Product Development
  .
• Hands‑on experience with user needs
  , design inputs/outputs
  , V&V,
  DHF/DMR management, and design reviews
  .
• Strong risk management experience including FMEAs and risk file maintenance.
• Ability to partner effectively with multi‑disciplinary engineering teams.
• Exposure to supplier quality activities such as audits and corrective action management.
• Experience with PPAP, Gage R&R, or analytical measurement tools is a plus.
• CQE or Six Sigma Black Belt certification is a plus but not required.
• Strong follow‑through, organizational skills, and comfort managing multiple technical projects simultaneously.

• High‑impact role supporting ongoing product development and design improvement initiatives.
• Opportunity to shape and elevate Design Control practices across multiple product lines.
• Close collaboration with R&D and engineering teams across mechanical, electrical, and software systems.
• Significant organizational growth supporting long‑term career advancement.

Interested candidates are encouraged to apply or reach out directly for a confidential conversation.

West Leland Group is a boutique search firm focused on Quality, Regulatory, and Engineering roles for medical device, biotech, and pharmaceutical companies. With deep industry expertise and a long‑term approach, we help innovative organizations build teams that drive better health outcomes. Thoughtful Search. Purposeful Hiring.

West Leland Group is an equal opportunity search partner. Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. This is a direct‑hire position with a confidential client in the medical device industry.

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Quality Assurance, Engineering, and Design
• Industries:
  Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)