Merrimack Manufacturing · 19 hours ago
Supplier Quality Engineer
Manchester, NH
Full-time
Onsite
Entry, Mid Level
2+ years expMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. This position will help manage and improve the overall quality of our supply chain partners, ensuring compliance with ISO 13485 and FDA requirements. The role involves working closely with various teams to address quality issues and drive continuous improvement throughout the product lifecycle.
ConstructionIndustrial ManufacturingMachinery ManufacturingManufacturingMechanical Engineering
Responsibilities
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, Manufacturing Engineers and Quality Engineers 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
Qualification
Required
2+ years of experience in a Quality Assurance role, or with a medical device manufacturing company
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
Bachelor's in Engineering or related experience
Preferred
Experience as a certified quality auditor or supplier auditor is a plus
Company
Merrimack Manufacturing
Merrimack Manufacturing is an industrial machinery manufacturing company that provides technical solutions for construction equipment.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase