In this role, you will provide quality assurance support for all aspects of New Product Introductions, focusing on long-term strategies for Quality, Risk Management, Inspection & Testing, and Suppliers to ensure product competitiveness and compliance with domestic and international regulations.

MAJOR DUTIES/RESPONSIBILITIES:

• Prepare and implement programs and processes to ensure compliance with the company's high quality standards. 
• Support validation, MSA remediation, PFMEA (Risk Management), PPAP, QMS integration: training, acceptance activities, part certification, NCs at suppliers and deep dive into P&PC.
• 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.
• 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)