Help manage and improve the overall quality of our supply chain partners, and help ensure that we are compliant to ISO 13485 and FDA requirements as relates to our suppliers and supplied parts. This position will be part of our Quality Management team, but will work extremely closely with our Material Management team as well. This role will be the key conduit to our suppliers on all matters pertaining to quality, engineering and continuous improvement throughout the product lifecycle.
- Applying knowledge of medical product technologies and processes, provide input to Quality and Material Management in the identification, selection and qualification of suppliers.
- Ensure key suppliers are audited per applicable quality processes.
- Provide key input to the Supply Chain and Quality teams on supplier performance as part of the ongoing management of the Approved Supplier List.
- Establish supplier quality agreements with approved suppliers as required.
- Facilitate the review and approval of supplier initiated changes and communicate the approved changes through Quality and to the appropriate departments.
- Assist in resolving supplier quality issues and perform/implement root cause and corrective actions with suppliers as needed.
- Work closely with suppliers to establish appropriate quality processes to ensure compliance with applicable requirements.
- Look for opportunities to drive preventive actions and continuous process improvement with our suppliers.
- Provide quality performance and input on technical capabilities to the Material Management team for scorecarding our key suppliers.
- Work with the Material Management and Operations teams to identify and execute cost reduction opportunities.
- Assist as needed with customer audits and regulatory audits.
- Provide recommendations for improvements and help drive best practices to SOPs pertinent to QA GMP Compliance activities.
- Bachelor’s in Engineering or related experience
- 5+ years of experience in a GMP role within a medical device manufacturing environment
- Experience as a certified quality auditor or supplier auditor is a plus
- Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820
- Hands-on experience in supplier qualification, supplier audits, working with suppliers to resolve quality issues
- Strong investigation and root cause analysis skills and driven to fully and completely resolve problems
- Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
To apply for this job email your details to Jay@vantagepointrecruiting.com