New 
Engineer, Supplier Development Quality
 Spectraforce Technologies | |
 United States, Maine, Scarborough | |
 Oct 31, 2025 | |
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Position Title: Engineer, Supplier Development Quality Work Location: Scarborough, Maine, 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. | |