Supplier Quality Engineer
- Manchester, NH
- Permanent
- Full-time
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.
- 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