Role: Supplier Development Quality Engineer
Location: Scarborough, ME - 04074
Duration: 4 Months
Job Description
- 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 customerrequirements.
- 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 resolveissues; 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.
- 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 SupplierEngineering
- Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
