Quality Engineer Instrumentation

STEMCELL Technologies Inc; Vancouver; On-site; CAD 71,000 - 97,000; Full time

Job summary

A leading biotechnology company in Vancouver is seeking a Quality Engineer to join their Instrumentation team. This role emphasizes the support of the Quality Management System, ensuring compliance with medical device regulations. Candidates should possess a Bachelor's Degree in Engineering and a minimum of three years of relevant experience. The position offers a competitive salary, excellent benefits, and opportunities for career development within a collaborative and dynamic team environment.

Benefits

Competitive salary

Excellent benefits

Career development opportunities

Qualifications

• Minimum 3 years of industry experience is required.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is a plus.

Responsibilities

• Support the Quality Management System for instruments.
• Lead development of metrics for process effectiveness.
• Maintain document control and review design changes.
• Conduct root cause investigations for non-conformance.
• Participate in various audits by regulatory bodies.

Skills

Technical report writing

Understanding technical documents

Quality Management System experience

Project ownership

Education

Bachelor’s Degree in Engineering

Job description

Job Description Summary

Our Quality Engineering team is expanding and we are looking for new people to join Canada’s largest biotechnology company! If you're passionate about supporting, developing, and implementing strategies to maintain compliance, this role as a Quality Engineer in our Instrumentation team is for you! In this role, you will have the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues and fill potential gaps. STEMCELL Technologies is a dynamic workplace that pursues cutting edge technologies and practices which translates to you managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.

Job Description

Duties and Responsibilities

• Support the Quality Management System (QMS) as it pertains to our instruments, ensuring compliance with applicable medical device regulations and standards
• Leads the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement
• Maintain document control, prepare SOPs, Work Instructions and other Quality Records, and review of design changes that support the change control process
• Lead root cause investigations and activities for non-conformance and corrective and preventive action. Communicates with suppliers, contract manufacturers and internal departments for any issues and non-conformance
• Participate in the internal audits, supplier audits, customer audits and/or ISO and other compliance audits by regulatory bodies

Knowledge and Qualifications

• Bachelor’s Degree in Engineering, with a minimum 3 years of industry experience
• Excellent technical report writing and strong ability to understand and analyze technical documents
• Experience with Quality Management System requirements, including non-conformance reports (NCRs) and Supplier Corrective Action Requests (SCARs)
• The ability and the drive to work in a fast-paced environment and have a strong sense of project ownership are essential
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certifications would be an asset

#Nonbench #AB-Hybrid #LI-AB1

STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

The annual salary for this job ranges from $71,200.00 - $96,400.00.

STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.

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