Manager, Quality Engineering

Job Number
GB#7226
Job Title
Manager, Quality Engineering
Salary Range
DOE – salary + bonus
Benefits
RRSP matching, medical/dental from day 1, relocation expenses (if applicable)
Category
Healthcare & Biotech Jobs
Industry
Medical & Pharmaceutical
Location
Vancouver - BC
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Our client is a global manufacturer of medical devices with a strong focus on respiratory products. We are looking for a Manager, Quality Engineering to join their team based in Vancouver, BC. Our client manufactures products that have embedded software and a video component.

This individual is responsible for providing Quality Engineering leadership in direct support of medical device product development and manufacturing operations. Our client is open to relocating the right candidate to Vancouver for the position. This role includes leadership of a team of 5. We are looking for an experienced quality team to join their team, with experience in medical device manufacturing.

Responsibilities:

· Lead the team of Quality Engineers, Inspectors, Technicians, and Supervisors by establishing goals, providing work direction, managing performance, and developing talent

· 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.

· Leverage industry best practices, internal signals (audit), and lessons learned to lead continuous sustainable improvement in areas of responsibility

· Support or lead cross functional investigations of complex product problems

· Identify and manage corrective actions resulting from these investigations

· Maintain effective Quality Metrics

· Define and execute activities to resolve misses in performance

· Represent Quality for the Vancouver location

· Regularly interact with site leadership and Quality leaders at headquarters

· Maintain spending controls to ensure department budget is met

Qualifications:

· 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

· 3+ years of experience in medical device manufacturing or product development

· Strong leadership experience

· 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

· ASQ Certified Quality Engineer (CQE) and Certified Manager of Quality and Organizational preferred

· 10% Domestic and international travel is required

Recruiter Info

Author Profile Picture
Bio

Jessica Miles

jessica

Jessica Miles is one of our very successful Senior Recruiters here at Goldbeck. She specializes in recruiting professionals for sales, operations, and senior management in Production & Operations, Mining, Oil, & Gas, Forestry & Agriculture, Industrial Sales, Life Sciences & Biotech. Jessica has successfully filled very difficult searches for demanding clients across Canada, the USA, Europe and Asia. Jessica takes great pride in the time and effort she takes to understand her client’s requirements. She then methodically and thoroughly scours all passive and active candidates in the relevant labour markets. Like all of our recruiters at Goldbeck Recruiting, Jessica uses the most up-to-date digital candidate sourcing tools and methodology. This is combined with candidate evaluation techniques using precise matrix systems and thorough face-to-face interviews.

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