Role: Supplier Development Quality Engineer
Location: Scarborough, ME (Onsite)

Key Responsibilities:

• Manage supplier changes through the change management system.
• Review Supplier Validation Protocols to ensure they meet regulatory and customer requirements.
• 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.
• 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.
• 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.
• Work closely with the engineering team to schedule and drive and review purchased product first article inspections, capability studies, gage R&Rs, etc.

Qualification:

• 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.