Senior QA Engineer, Medical Devices & Compliance
NCSL International
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Job summary
Arthrex, Inc. is a global medical device company seeking a Senior Quality Assurance Engineer for its Ave Maria, FL facility. You will support the Quality Manager across the lifecycle of Class I-III medical devices, including new product development and maintenance of released products.
The role emphasizes design controls, risk management, and process validation in a regulated environment. The candidate will lead or participate in audits, CAPAs, NCRs, and continuous improvement projects, with
Qualifications
- Bachelor's degree in Engineering is required.
- Minimum 5 years of quality engineering experience in a highly regulated industry.
- Knowledge of development methodologies including Design Controls, GD&T, DOE, Verification and Validation.
Responsibilities
- Review design drawings for tolerance, inspect-ability, and quality issues.
- Lead or support PFMEAs and risk assessments.
- Lead or support IQ/OQ/PQ validation and metrology activities.
Skills
Education
Tools
Job description
Arthrex, Inc. is a global medical device company seeking a Senior Quality Assurance Engineer for its Ave Maria, FL facility. You will support the Quality Manager across the lifecycle of Class I-III medical devices, including new product development and maintenance of released products.
The role emphasizes design controls, risk management, and process validation in a regulated environment. The candidate will lead or participate in audits, CAPAs, NCRs, and continuous improvement projects, with
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