Quality Assurance Specialist
4 weeks ago
Contribute to the success of a global medical device product line utilized in surgeries.
About the Role:
We are seeking a Quality Assurance Specialist to join our growing Quality team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices.
Key Responsibilities:
- Supports regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality control and assessment.
- Leads and implements various methodologies for product and process improvement.
- Reviews the adequacy and accuracy of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and more.
- Oversees the completion and maintenance of risk analyses.
- Manages the generation and completion of protocols and reports for test method validations.
- Collaborates with Manufacturing Engineers to review processes for new and existing products, coordinating process validations and capability studies, and recommending monitoring devices when appropriate.
- Develops inspection techniques and procedures to ensure product integrity in line with design specifications, responsible for writing, approving, and implementing Incoming, In-Process, and Final Inspection procedures.
- Ensures that the disposition of non-conforming materials meets all regulatory requirements and that corrective actions are adequate to prevent recurrence.
Requirements:
- Relevant experience in Quality Assurance Engineering
- Bachelor's Degree in a Science-related field
- Over 3 years of experience in a cleanroom environment
- Strong background in medical device manufacturing
- Solid understanding of statistical tools and the effective use of Design of Experiments (DOE) for recommendations
- Excellent communication and interpersonal skills
- Familiarity with FDA regulations, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs
What's Included in the Offer:
- Competitive base salary ranging from $80,000 to $95,000, based on experience and skills
- Bonus potential of up to 5%
- Comprehensive benefits package that includes medical, dental, and vision coverage
- Life and Accidental Death & Dismemberment (AD&D) insurance
- Short-term disability coverage
- 15 days of paid time off (PTO) plus 10 holidays
- 401(k) plan with a 6% company match
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