Supplier Quality Engineer

5 days ago

Milford, MA, United States Life Science Staffing Full time
Position Summary:
The responsibilities of the supplier quality engineer include securing supplies and parts for the assembly line, reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues.
Essential Functions:
  1. Work with Supplier Quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement.
  2. Play a key role in Supplier onboarding and qualification.
  3. Evaluate the Supplier Manufacturing Capability through visits, technical discussions, and perform Supplier Revaluations.
  4. Work with key Suppliers closely to Manufacture and/or test components. Review the SOP's, Work Instructions and Technical notes from Key suppliers to manufacture and/or test Components.
  5. Issue and monitor SCAR's, work with suppliers to achieve timely and comprehensive corrective/preventive actions on Non conformances.
  6. Coordinate Supplier change request/notification, and deviation.
  7. Perform Supplier audits and develop corresponding audit reports.
  8. Support implementation and maintenance of supplier agreements as needed.
  9. Comply with ISO 13485, ISO 14971, U.S FDA regulations, EUMDR, and other regulatory requirements, company policies, operating procedures.
  10. Collaborate with Suppliers and internal Stakeholders to drive Quality improvements that minimize the Costs of Quality and support implementation of Supplier/Engineering Changes, New Product Introductions and Transfers.
  11. Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy and Supplier Owned Quality deployment.
  12. Implement AS9145 (APQP/PPAP) elements such as MSA's, PFMEA's & control plans.

Education, Training, and Experience:
  1. Bachelor's degree in Mechanical or Electrical or Industrial Engineering plus at least 4 plus years of progressively more responsible experience in manufacturing and quality.
  2. Six Sigma Certification (preferred).
  3. Experience Creating Vendor Qualification System
  4. Experience with key supplier controls, including document and change controls.
  5. Experience in process validation, design controls, risk management, CAPA, and SCAR
  6. Product development process experience.
  7. Basic computer knowledge, including Microsoft Office Suite.

Preferred Experience:
  1. Strong quantitative and analytical skills.
  2. In-depth knowledge on Six Sigma tools and Lean methodologies.
  3. Strong aptitude with Electrical and Mechanical Components.

Physical and Environmental Considerations:
  1. Must be able to lift up to 20 pounds.
  2. Must be able to sit for long periods of time.
  3. Required use of standard office equipment including laptop, phone, copier, etc.

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