Medical Device Quality Specialist
7 days ago
Job Overview:
Quality Assurance Associate
The successful candidate will be responsible for assisting in the maintenance of the effectiveness of our Quality Management System (QMS) and driving continuous improvement initiatives. This includes managing day-to-day QA activities, including supplier relationships, audits, and quality issue resolution.
Key Responsibilities:
- Maintain QMS schedules, including supplier and internal audits, management review, and documentation updates.
- Support the team to ensure product manufacture and testing meets requirements.
- Build and maintain strong relationships with suppliers and monitor their performance.
- Investigate and resolve product quality problems, including root cause analysis and corrective actions.
- Ensure incoming materials meet specifications and work with engineering on quality concerns.
Requirements:
- Bachelor's degree in engineering or science; Quality certification in ISO 13485 required.
- At least 4 years of experience in medical device QA, with thorough knowledge of ISO 13485 and EU MDR.
- Lead auditor certification and regulatory certifications desirable.
- Proven project management and problem-solving skills.
About Us:
We are a life-science recruitment company partnering with innovative companies that develop cutting-edge medical devices. If you're passionate about quality assurance and medical devices, we'd love to hear from you
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