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Senior Supplier Quality Engineer
Merit Medical OncologySupplier Quality Engineer responsible for supplier development and ensuring compliance in medical device manufacturing. Collaborating with suppliers and internal teams to improve quality and performance.
About the role
Key responsibilities & impact- Executes supplier development engineering for the Company’s supplier base
- Works with manufacturers and service suppliers to ensure product / services provided meet company requirements
- Interfaces with other departments as well as with suppliers and other external parties on issues related to product manufacturability and product changes
- Plans, organizes, directs and reports on all engineering supplier development activities such as raw materials changes, contracted designed and manufactured items, packaging materials, service providers, and laboratories to assure procurements meet or exceed the requirements
- Works directly with the Company manufacturing plants and the contract manufacturer to integrate the incoming performance of raw material and component supplier to collaboratively resolve issues
- Assures that customer technical requirements are adhered to by supplier and that a quality system is maintained
- Develops procedures for supplier management to establish world class supplier processes
- Conducts programs designed to improve supplier performance, productivity, and process validation
- Supports quality issues through Supplier Corrective Action Reports as needed and provides assistance to develop corrective actions in an effort to reduce and eliminate defects
- Manages cost savings initiatives with suppliers through integration into Merit manufacturing facilities
- Manages supply chain resiliency programs which include but are not limited to supplier consolidation, dual sourcing, acquisition integrations
- Responsible for ensuring that the cost savings initiatives and supply chain resiliency programs are communicated effectively to senior leadership
- Develops reports on supplier performance for company management
- Liaises between corporate and manufacturing sites for the deployment and communication of needs and new or improved requirements
Requirements
What you’ll need- Education and/or experience equivalent to bachelor's degree in engineering or related field
- A minimum of eight (8) years of experience in engineering in the medical device industry
- Working knowledge of the Quality System Regulation and ISO 13485 quality system standards
- Familiarity with process development and process change
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- Six Sigma/Lean certification (preferred)
Benefits
Comp & perks- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
supplier development engineeringproduct manufacturabilityprocess validationsupplier managementcost savings initiativessupply chain resiliencyquality systemprocess developmentcorrective actionsISO 13485
Soft Skills
communicationorganizationalleadershipcollaborationproblem-solvingreportingplanningdirectinginterfacingassurance
Certifications
Six SigmaLean