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Supplier Quality Engineer

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MillenniumSoft Inc

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Location:
United States , Zelienople

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Category:
Manufacturing

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Contract Type:
Employment contract

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Salary:

27.00 - 32.00 USD / Hour
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Job Description:

The Supplier Quality Engineer is accountable for supplier/vendor selection, qualification, and approval, as well as supplier process qualifications, supplier monitoring, and supplier corrective action requests. This position will have direct interaction with the Procurement, Division R&D, Manufacturing, Service, and Manufacturing Engineering groups to support new product introduction, continuous improvement, and sustaining manufacturing activities. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. An understanding of the application of quality standards and regulations (21CFR 820, ISO-13485) is necessary.

Job Responsibility:

  • Supplier/vendor selection, qualification, and approval
  • Supplier process qualifications, supplier monitoring, and supplier corrective action requests
  • Direct interaction with the Procurement, Division R&D, Manufacturing, Service, and Manufacturing Engineering groups to support new product introduction, continuous improvement, and sustaining manufacturing activities

Requirements:

  • 1-3 years’ experience in Medical Device manufacturing or similarly regulated industry required
  • Proven ability to develop and/or approve supplier PFMEAs, Control Plans, Measurement System Analysis, Special Process Validation, FAI, Routine Lot Acceptance activities is required
  • Experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) required
  • Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills required
  • Demonstrated strong attention to detail and “do it right the first time” attitude required
  • Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
  • BS in Electronics/Electrical Engineering, Mechanical Engineering, Bio-Medical Engineering, or equivalent required

Nice to have:

  • 2+ years of auditing experience preferred
  • Basic knowledge of electro-mechanical devices preferred
  • Familiarity with ISO14971 and associated Risk Management Processes preferred

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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