We are recruiting for a very specific position –
Supplier Quality Engineer - to 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 team, and will work extremely closely with our Incoming Inspection, Engineering and Material Management team.This role will be the primary driver of disposition and closure of Supply based NCR activity. This role will also weigh in on all matters pertaining to quality, engineering and continuous improvement throughout the product lifecycle.
How you will make an impact:
- Assist inspection with evaluating cosmetic specifications and other intricate component requirements requesting input and communication with QE/ME as needed
- Interface with Incoming Inspection, discuss results, document disposition and required approvals to ensure timely closure of Nonconformance Reports.
- Serve as key contributor at weekly Incoming Inspection NCR MRB meeting
- Utilize relationships with MMC incoming inspection group and the supplier to investigate differences between measurements
- Communicate failures to suppliers, request SCARs where necessary and document effectiveness of corrective actions
- Work with Supply Chain to attain RMA numbers, ensure dispositions are carried out per NCR approval
- Generate and Distribute Scorecards to suppliers
- Conduct ASL updates in MMC PLM system for new suppliers, Supplier Change Notifications etc.
- Interface with suppliers, Mfg Eng and QEs to evaluate potential component issues. Walk down MMC processes vs supplier processes and determine root cause
- Work with Supplier Development and Sr SQE to schedule telecons, investigate process control issues or breakdowns, identify high risk suppliers, schedule for cause audits, etc
- Facilitate the review and approval of supplier-initiated changes requests, and communicate the approved changes through Quality and to the appropriate departments
- Look for opportunities to drive preventive actions and continuous process improvement with our suppliers
- 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
To be successful in this role, you will need the following skills and experience:
- Bachelor’s in Engineering or related experience
- 2+ years of experience in a Quality Assurance role, or with a medical device manufacturing company
- Experience as a certified quality auditor or supplier auditor is a plus
- Familiarity with ISO 13458:2016 and FDA 21 CFR Part 820
- Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
- A demonstrable ability to work with cross-functional teams comprised of members within and outside of our organization
- Ability to work with CAD files and interpret mechanical drawings
- Ability to analyze data for accuracy and correctly interpret results
- Microsoft Office proficiency
- Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel
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