Quality Engineering Manager, to directly support medical device product development and manufacturing operations.

Quality Engineering Manager, to be responsible for providing Quality Engineering leadership in direct support of medical device product development and manufacturing operations.
 
Must haves:

• Bachelor of Science or related degree is required; Biomedical, Electrical or Mechanical Engineering discipline preferred
• 5+ years of work experience demonstrating a strong level of expertise in Quality Engineering is required
• Knowledge of FDA (21CFR820) and ISO (13485/14971) requirements

Nice to have:

• ASQ Certified Quality Engineer (CQE) and Certified Manager of Quality and Organizational preferred
• 3+ years of experience in medical device manufacturing or product development or in a similar regulated environment (Automotive, Aerospace)

 
The role:

• Lead the team of Quality Engineers, Inspectors, Technicians, and Supervisors (team of 6)
• Ensure adherence to design control requirements in new product development
• Execute Quality deliverables in support of project timelines
• Provide expertise to cross-functional development teams in requirements flow-through, risk management, reliability, test method development, validation, and design verification and validation
• Partner with Operations, to ensure compliance of manufacturing operations to applicable requirements (21CFR820 / GMP)
• Identify compliance risks and develop and execute plans to mitigate them
• Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures especially in the areas of production and process controls, receiving, inspection, calibration, management of non-conforming product, environmental monitoring, process validation, quality records, and change control.
• Support or lead cross functional investigations of complex product problems
• Identify and manage corrective actions resulting from these investigations

Points to note:

• 10% Domestic and international travel is required