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Supplier Quality Engineer II
1 month ago
Pay: $45.00/hr - $55.00/hr
Contract: W-2, 12 months, extensions likely, conversion possible - cannot provide sponsorship or support C2C at this time.
Responsibilities:
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplierrelated problems as they occur.
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Bachelor's Degree in Engineering/Scientific/Electronic or technical field
- 4+ years of relevant experience.
- Strong knowledge of change control processes.
- Experience leading, supporting, reviewing, and approving supplier change requests, validation, MSA, SCAPA, TMV, PPAP, Risk Assessments, etc.
- Experience working with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including SPC, Quality Plans, Control Plans, and FMEAs
- Familiarity with the medical industry requirements such as ISO 13485
- Project Management background - experience supporting, coordinating, and/or leading projects.
- Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA).
- Experience in the development of new or existing medical devices.
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