Senior Quality Engineer
Integra LifeSciences · Facility, MA
QualityFull-time$82k–$113kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Quality Engineer role at a medical device company focused on product lifecycle management, process improvement, and quality system compliance. Position involves quality engineering tools, risk management, problem-solving, and mentoring of engineering and technical staff.
What they're looking for
- Engineering or technical degree with 5+ years experience, or master's degree with 3+ years experience
- Strong written and oral communication skills in English
- Proficiency in MS Office Suite and statistical analysis software
- Experience writing and executing IQ/OQ/PQ validation documents
- Experience in regulated medical device or pharmaceutical environment
- Familiarity with health, safety, and environmental manufacturing regulations
- Experience with electronic QMS systems, preferably Trackwise
What you'll be doing
- Support quality improvement initiatives including process and product characterizations for continuous improvements
- Initiate, analyze, investigate, and close nonconforming reports and CAPA activities
- Conduct internal and supplier audits per ISO-13485 and 21CFR820 standards
- Develop process monitoring and control methods, including FMEA activities
- Lead validation planning, execution, and review activities; mentor engineers and technicians
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.