Job Vacancy Supplier Quality Engineer – 1-3 yrs exp in Medical Device manufacturing or regulatory Industry Millenniumsoft


Job title: Supplier Quality Engineer – 1-3 yrs exp in Medical Device manufacturing or regulatory Industry

Company: Millenniumsoft

Job description: Position : Supplier Quality Engineer

Location : Zelienople, PA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Level Of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

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 Details:

  • Lead production part approval process (PPAP) activities with the supplier, including but not limited to, first article inspection, process qualification, control plans, PFMEA, etc.
  • Actively participates in activities for supplier qualification, including supplier audits
  • Tracks supplier quality trends and initiates supplier corrective actions to resolve issues
  • Manages assigned corrective actions and drives them to closure
  • Trends, analyzes, and reports on quality data to improve products and processes

Candidate Qualifications:

  • BS in Electronics/Electrical Engineering, Mechanical Engineering, Bio-Medical Engineering, or equivalent required
  • 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
  • ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor certification (or equivalent) or ability to obtain it is required
  • Basic knowledge of electro-mechanical devices preferred
  • Familiarity with ISO14971 and associated Risk Management Processes preferred
  • 2+ years of auditing experience preferred

Expected salary:

Location: Zelienople, PA

Job date: Fri, 15 Jul 2022 22:30:40 GMT

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