Senior Engineer II, Quality Validation
Integra LifeSciences · Facility, MA
QualityFull-time$94k–$130kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Engineer II in Quality Validation at Integra LifeSciences responsible for leading validation activities including packaging, equipment qualification, and process validation. This individual contributor role involves supporting new product introductions, product transfers, and validation projects in a regulated medical device environment.
What they're looking for
- Bachelor's degree in engineering or science discipline with 8+ years experience, or Master's degree with 5+ years, or Doctorate with 3+ years
- 1–3 years validation or quality assurance experience in medical device or pharmaceutical environment
- Subject matter expertise in at least one validation area: packaging, equipment qualification, process validation, test method, cleaning, utility, temperature mapping, or statistical sampling
- Working knowledge of applicable regulations (cGMP, cGLP, QSR, ISO) and their industry interpretation
- Excellent technical writing, organizational, and communication skills with project management capability
- Understanding of risk-based sampling, risk management, clean room practices, and ability to read engineering documentation
What you'll be doing
- Generate, execute, and approve qualification and validation protocols for NPI, product transfers, and validation projects
- Determine scope and path forward for validation requests; contribute to risk management and PFMEA activities
- Serve as validation subject matter expert on cross-functional teams and mentor non-senior validation staff
- Coordinate scheduling, material allocation, and personnel alignment; manage contract validation resources and supervise validation assignments
- Ensure compliance with cGMP, cGLP, QSR, and ISO requirements; support FDA inspections, audits, and documentation review
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.