Senior Quality Engineer
$81.65k - $112.7kIntegra LifeSciences Corporation
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $81,650.00 - $112,700.00 USD Salary
Vacancy posted 21 days ago
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