Supplier Quality Engineer

3 weeks ago


Scarborough, United States ICONMA Full time
Supplier Quality Engineer
Location: Scarborough, ME

Description:
  • The position of Supplier Quality Engineer is within our Infectious Disease Developed Markets business unit located at all sites under Client Diagnostics Scarborough QMS.
  • This role will perform daily activities required to ensure that all purchased or otherwise received materials, products and services that can impact the quality of product or service provided conform to predefined requirements and quality attribute
  • 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.
  • 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.
  • Perform external audits, as required, based on the published audit schedule and/or as needed if suppliers are struggling to achieve established quality metrics.

Qualifications:
  • 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 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.
  • High level of proficiency in Microsoft Office Suite of software applications is required.
  • Exceptional documentation and technical writing skills is required.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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