Senior Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled Quality Assurance Engineer to join our team at Michael Page. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and integrity of our medical device products.
Key Responsibilities:
- Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
- Lead and implement product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials, Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Lead in the completion and maintenance of risk analysis.
- Develop various inspection techniques and procedures to ensure product integrity to design specifications.
- Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Requirements:
- Relevant Quality Assurance Engineering Experience
- Bachelor's Degree (Science Related)
- 3+ years of experience in a Cleanroom environment
- Strong Medical Device Manufacturing Experience
- Good knowledge of statistical tools and appropriate use of Design of Experiments (DOE) when developing recommendations
- Excellent communication and interpersonal skills
- Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPs
What We Offer:
- Competitive base salary between $80,000-$95,000, depending on experience and skills
- Bonus opportunity up to 5%
- Comprehensive benefits package including Medical, Dental and Vision
- Life and AD&D Coverage
- Short-term disability coverage
- 15 PTO Days + 10 holidays
- 401(k) with 6% company match
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