Overview
Supplier Quality Engineer Jobs in Manchester, NH at Merrimack Manufacturing
Title: Supplier Quality Engineer
Company: Merrimack Manufacturing
Location: Manchester, NH
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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