Supplier Quality Assurance Engineer Remote - 22770

Our client, a Global Medical Device Manufacture has an immediate opening for a Supplier Quality Assurance Engineer for a 12 Month Contract. Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Position Description (Principle Duties and Responsibilities)

The experienced Supplier Quality Assurance Engineer will collaborate with suppliers to assure the quality of their products, materials, components and/or operations. Monitors supplier performance and supports efforts to develop and implement changes to improve the production process. Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.
 
 

Day-to-Day Duties May Include:

• Supports engineering change orders, process change orders, and first article (FA)/production part approval process (PPAP)
• Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Understands and applies standard engineering principles.
• Analyzes reports and defective products to determine trends and recommend corrective actions.
• Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to Supplier Quality improvement programs.

Qualifications:

• BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Computer Engineering, or related Engineering degree. 
• Minimum 2 years of experience in quality engineering in a regulated environment. 
• Strong preference given to candidates with experience in new product development, focused on quality engineering-related activities. 
• Strong preference given to candidates with 4+ years of experience and with experience specific to the medical device industry. 
• Working knowledge of risk analysis methodologies, GD&T, PPAP, SPC, Root Cause Analysis, and Statistics. 
• Working knowledge of FDA QSRs, ISO 13485 and ISO 14971 standards. 
• Certified Quality Engineer (CQE) or other relevant ASQ certification preferred. 
• Six Sigma and/or Lean certifications preferred. 
• Class II/III medical device experience preferred.