Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Our client is searching for a Quality Engineer to support various activities for their specimen management instruments.
- This role is critical in ensuring the ongoing quality and compliance of supplierprovided components and materials.
- The ideal candidate will work crossfunctionally with internal teams and external suppliers to address quality issues support design control and change management and maintain a robust supplier quality system in alignment with regulatory requirements.
- Serve as the primary quality liaison for sustaining engineering efforts related to change control and design control.
- Monitor and improve supplier performance through metrics audits and continuous improvement activities.
- Collaborate with R&D Manufacturing Regulatory and various quality teams to support design changes material changes and process improvements.
- Maintain documentation and records in compliance with FDA 21 CFR Part 820 ISO 13485 and ISO 1497
- Support supplier quality risk management activities including risk assessments and periodic reviews.
- Assist with Process Validation efforts as well as give insight into the Assurance efforts on the operations team
Requirements:
- 57 years of experience in quality engineering within the medical device industry.
- Strong analytical problemsolving and communication skills.
- Experience working directly with suppliers including audit quality agreements and performance management.
- Familiarity with quality tools (e.g. 8D FMEA root cause analysis CAPA).
- Strong cross functional communication skills.
- Strong understanding of design control and change control.
Employment Type
Full Time
