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Quality Engineer
4 weeks ago
WHAT YOU'LL DO:
- Identify internal requirements and external laws, regulations, guidance, and standards (LRGS) relevant to the division's quality systems.
- Ensure that internal activities and external partnerships adhere to applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
- Interpret internal requirements and external LRGS, integrating them into business processes internally or with external partners.
- Maintain and communicate monthly metrics related to quality systems.
- Review and approve product design changes and Quality System documentation.
- Manage external partner files and create related Quality System documents.
- Review external partnership assessment forms and assist in onboarding and maintenance activities.
- Participate in external inspection/audit activities.
- Perform additional duties as assigned by Management.
EDUCATION AND EXPERIENCE YOU’LL BRING:
- Bachelor's Degree in Life Sciences, Physical Sciences, Engineering discipline, or equivalent technical field.
- Minimum of 0-2+ years of experience in Quality Assurance.
- Minimum of 0-2+ years of experience in the Medical Device manufacturing or pharmaceutical industries.
- Working knowledge of applicable regulations and standards such as FDA QSR and ISO 13485.
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