Quality Assurance Specialist
3 weeks ago
At Enovis, we strive for excellence in medical technology. As a key member of our Quality Assurance team, you will play a vital role in driving the industry forward through transformative patient care and better outcomes.
Job Summary: We are seeking a talented and experienced Supplier Quality Engineer to join our team. The ideal candidate will have a deep understanding of engineering principles and problem-solving techniques, with a focus on designing, implementing, and maintaining quality assurance protocols and methods.
Key Responsibilities:
- Develop and issue procedures to ensure compliance with FDA QSR regulations, ISO standards, and other relevant requirements.
- Support the New Supplier Approval process as Quality lead, ensuring adherence to local and global work instructions.
- Conduct facility, product-specific, and quality system audits to verify supplier capabilities and quality.
- Investigate supplier-caused product problems, drive root cause identification, and manage Supplier Corrective Actions.
- Develop and present supplier metrics for review, including supplier defective parts per million (DPPM) and yield trends.
Requirements:
- Bachelor's degree in science or engineering, with 3+ years of applicable experience (CQA or CQE certification preferred).
- Bilingual Spanish/English required.
- Requires certification to perform audits, with experience in Medical Device engineering standards and concepts.
About Enovis: Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.
Equal Employment Opportunity: Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria, without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.
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