Quality Engineering Manager, to directly support medical device product development and manufacturing operations.
Job Type: Permanent
Positions to fill: 1
Start Date: Jul 25, 2022
Job End Date: Jul 25, 2022
Pay Rate: Salary: Negotiable
Job ID: 121577
Location: Vancouver, Victoria
Quality Engineering Manager, to be responsible for providing Quality Engineering leadership in direct support of medical device product development and manufacturing operations.
- 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
- 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)
- 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
- 10% Domestic and international travel is required