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Supplier Quality Engineer

1 month ago

Scarborough, United States Collabera Full time
RESPONSIBILITIES:
  • 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.
  • 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.
BASIC QUALIFICATIONS | EDUCATION:
  • BS in Engineering, Manufacturing, Biology or related discipline or equivalent combination of education and experience.
  • 2+ years’ experience in medical device industry, preferably in Quality or Supplier Engineering.
  • Demonstrated proficiency using MS 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.
  • High level of proficiency in MS 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.
  • Ability to interpret data and make sound judgments based on those interpretations is required.
  • Must be able to adapt to quickly changing priorities and schedules.
  • Ability to maintain good working relationships with all co-workers and outside contracts is required.