Position: Senior Quality Engineer
Location: Hybrid in Austell, GA
Duration: Full-Time, Permanent
Salary: $85,000-$100,000. Exact compensation may vary based on several factors, including skills, experience, and education.
We are seeking a highly experienced and collaborative Senior Quality Engineer to join our Quality team. This role will be instrumental in leading risk management activities, supporting new product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation.
Minimum Required Qualifications:
- Bachelor’s degree in engineering, life sciences, or related technical discipline.
- 5+ years of experience in quality engineering, product development, or manufacturing with the medical device industry.
- Demonstrated experience with leading risk management and design control activities.
- Solid understanding of statistical methods used in capability analysis, trend analysis, sampling plans, and data interpretation.
- Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
- Familiarity with Class I medical devices and U.S. market requirements
- Proven ability to mentor cross-functional teams and drive quality initiatives.
- Excellent communication, problem-solving, and organizational skills.
Preferred Qualifications:
- Master’s degree or advanced certification (e.g., ASQ CQE, CQA).
- Experience with EU MDR technical documentation and regulatory submissions.
5-10 years96
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Job Description
Download ResumePosition: Senior Quality Engineer
Location: Hybrid in Austell, GA
Duration: Full-Time, Permanent
Salary: $85,000-$100,000. Exact compensation may vary based on several factors, including skills, experience, and education.
We are seeking a highly experienced and collaborative Senior Quality Engineer to join our Quality team. This role will be instrumental in leading risk management activities, supporting new product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation.
Minimum Required Qualifications:
- Bachelor’s degree in engineering, life sciences, or related technical discipline.
- 5+ years of experience in quality engineering, product development, or manufacturing with the medical device industry.
- Demonstrated experience with leading risk management and design control activities.
- Solid understanding of statistical methods used in capability analysis, trend analysis, sampling plans, and data interpretation.
- Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
- Familiarity with Class I medical devices and U.S. market requirements
- Proven ability to mentor cross-functional teams and drive quality initiatives.
- Excellent communication, problem-solving, and organizational skills.
Preferred Qualifications:
- Master’s degree or advanced certification (e.g., ASQ CQE, CQA).
- Experience with EU MDR technical documentation and regulatory submissions.