Engineer, Supplier Development Quality

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.   
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 42.00/hr.