Staff Quality Engineer
Integra LifeSciences · Facility
QualityFull-time$73k–$102kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Staff Quality Engineer position focused on supplier process validation and continuous improvement for medical device manufacturing. The role involves leading IQ/OQ/PQ validations, managing supplier quality requirements, and supporting new product launches across surgical and tissue technology divisions.
What they're looking for
- Bachelor's degree in engineering or equivalent with 10+ years experience (or master's with 8+ years, or doctorate with 5+ years)
- Medical device or pharmaceutical manufacturing experience required
- Expertise in process validation, component qualification, IQ/OQ/PQ methodologies
- Strong data analytics and statistical analysis capabilities
- FDA regulatory compliance and cGMP knowledge
- ISO 9001 and ISO 13485 standards experience preferred
- Fluent English with excellent written and verbal communication skills
What you'll be doing
- Lead and verify supplier process validations for component and manufacturing requirements across divisions
- Communicate and confirm completion of validation protocols, critical-to-quality parameters, and qualification documentation
- Conduct root cause analysis, drive corrective actions, and perform supplier audits
- Drive continuous improvement initiatives through data analysis and identification of supplier quality enhancement opportunities
- Provide training on process validation concepts and mentor cross-functional teams on best practices
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.