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Supplier Development Quality Engineer
Supplier Development Quality EngineerSpectraforce Technologies • Scarborough, ME, United States
Supplier Development Quality Engineer

Supplier Development Quality Engineer

Spectraforce Technologies • Scarborough, ME, United States
1 day ago
Job type
  • Full-time
Job description

Position Title : Supplier Development Quality Engineer

Work Location : Scarborough, ME 04074

Assignment Duration : 6 Months

Work Schedule : M-F 8am-5pm EST

Position Summary :

Maintain the Supplier Quality Function, working closely with and supporting Purchasing and the New Product Development and Engineering team(s). Respond in a timely and professional manner to internal and external suppler requests that pertain to quality.

Key Responsibilities :

  • Manage supplier changes through the change management system.
  • Review Supplier Validation Protocols to ensure they meet regulatory and customer requirements.
  • Work closely with the engineering team to schedule and drive and review purchased product first article inspections, capability studies, gage R&Rs, etc.
  • Investigate and drive to completion root cause analysis of product quality issues and defects for new and sustaining purchased products and implement solutions to resolve issues; assist other personnel, as required, with the Corrective Action process specific to purchased components and / or services.
  • Manage the Supplier corrective action process, drive improvement to the ASL.
  • Utilize supplier Scorecards / metrics and analytical tools to quantify performance levels of individual suppliers and work with those suppliers to develop improvement plans to achieve quality performance goals.
  • Establish and execute priorities to achieve expectations.
  • Identify and implement continual improvement opportunities to streamline quality systems and processes.
  • Perform external audits, as required, based on the published audit schedule and / or as needed if suppliers are struggling to achieve established quality metrics.
  • Other duties as required.

Qualification & Experience :

  • BS in Engineering, Manufacturing, Biology or related discipline, or equivalent combination of education and experience.
  • 0-2 years' experience in medical device industry, preferably in Quality or Supplier Engineering.
  • Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
  • PREFERRED :

  • Familiarity with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD / IVDR. Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred.
  • Experience with change management systems is preferred
  • High level of proficiency in Microsoft Office Suite of software applications is required.
  • High level of attention to detail and accuracy is required.
  • Strong organizational skills and ability to prioritize tasks is required.
  • Exceptional documentation and technical writing skills is required.
  • Excellent verbal and written English language skills is required.
  • Ability to establish and maintain strong, effective working relationships with internal employees and external customers is required.
  • Ability to react quickly and adapt to changes in priorities, circumstances and direction is required.
  • Must be able to reason independently and work with minimum supervision.
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    Supplier Quality Engineer • Scarborough, ME, United States