Quality manager • coquitlam bc
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Overview
Verathon is looking for a Manager, Production Quality to become the newest member of our Quality Assurance Team located in our Burnaby, BC, Canada facility. The Manager, Production Quality provides Quality leadership in direct support of medical device manufacturing operations.
Responsibilities
• Lead the team of Quality Engineers, Inspectors, Technicians, and Supervisors by establishing goals, providing work direction, managing performance, and developing talent.
• 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.
• Leverage industry best practices, risk management processes, internal signals (. metrics and audit findings), and lessons learned to drive sustainable continuous improvement in areas of responsibility.
•Lead cross functional investigations of complex product quality issues. Identify root cause and manage corrective actions resulting from these investigations.
•Support design transfer activities from NPD to commercial production. Drive Production Quality deliverables per governing Design Control/New Product Development procedures.
•Maintain effective Quality Metrics; define and execute activities to resolve misses in performance.
•Regularly interact with site leadership and Quality leaders at Verathon headquarters.
• Maintain spending controls to ensure department budget is met.
• Other related duties as assigned.
This role is 100% on-site and not eligible for remote or hybrid work arrangements.
Qualifications
• Bachelor’s degree and 8+ years of Quality experience or Master’s degree and 6+ years of Quality experience. Degree in Biomedical, Electrical, or Mechanical Engineering preferred.
• 4+ years of experience in production quality roles.
• 3+ years of experience in medical device industry.
• 3+ years of experience as a people leader.
• Knowledge of FDA (21CFR820) and ISO (13485/14971) requirements.
• Excellent analytical, technical writing and verbal communication skills.
• Knowledge of quality improvement tools, including statistical methods.
• Ability to lift up to 35 pounds.
Additional Preferred Qualifications:
• ASQ Certified Quality Engineer (CQE) and/or Certified Manager of Quality/Organizational Excellence strongly desired.
Working Conditions:
• Significant use of standard office equipment, including computer keyboard, monitor, and mouse.
• Standing and walking in a manufacturing environment.
Salary range - $ $107,764.00 - $134,853.00 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
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