Quality Assurance Engineer

Position Description

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. 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.

MAJOR DUTIES/RESPONSIBILITIES:

• Collaborates with design division and/or legal manufacturer representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. 
• Collaborates with 3PL partners regarding physical containment and final disposition of Material Review Board product.
• Provides oversight and assistance in NC & CAPA.
• Prepare and implement programs and processes to ensure compliance with the company's high quality standards. 
• Experience in medical device manufacturing and the FDA QSR are preferred. 
• WORKING CONDITIONS
  • Fast-paced office environment. 
  • Medical Device, highly regulated environment. 
  • Mission-oriented culture, energized by the knowledge that our products save lives every day, and our work here has a very material impact on the delivery of healthcare around the world. 

REQUIREMENTS

• Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
• Minimum of 3-5 years in a quality role for a medical device company:  this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment. 
• MDR Experience a must. 
• Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable 
• Excellent verbal, written and interpersonal communication skills 
• Excellent problem solving and analytical skills 
• Excellent technical writing skills 
• High level of attention to detail and organization 
• Ability to multi-task and work independently 
• Ability to participate in cross-functional teams 
• Ability to read and interpret engineering drawings and other technical specifications preferred 
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)