Quality Assurance Documentation Specialist jobs

The Company is part of the Diploma Healthcare Group (DHG) which is a group of specialized medical device distribution companies operating in Canada, Australia, New Zealand and Ireland

Somagen Diagnostics Inc. was founded +30 years ago in Edmonton and has grown steadily to become Canada’s largest independent provider of medical diagnostic technology to laboratories, hospitals and clinics. Somagen is the exclusive Canadian distributor for many of the world’s most respected diagnostic product suppliers such as Polymedco, Phadia, and Sakura. We pride ourselves on being a highly technical sales organization providing leading support solutions to our clinical customers. Our proven business model has consistently achieved sustained growth even through challenging economic times.

Vantage Endoscopy and AMT Surgical are leading sales focused distribution organizations specializing in high tech niche diagnostic and therapeutic medical products focused on Endoscopy/GI Suite, GI Clinics and Hospital Operating Rooms across Canada.

The Quality Assurance (QA) / Quality Control (QC) Specialist is a pivotal member of the Technical Services team, responsible for upholding the highest standards of quality and regulatory compliance across products, systems, and services. Reporting to the National Director, Technical Services, this role leads quality assurance and control initiatives for Somagen Diagnostics, AMT Surgical, and Vantage Endoscopy.

As a subject matter expert, the QA/QC Specialist develops and standardizes quality processes, conducts advanced inspections and audits, and collaborates with cross-functional teams to integrate quality into every stage of service delivery. The position requires strong technical expertise, independent judgment, and the ability to mentor and influence service staff, driving continuous improvement and operational excellence.

Key responsibilities include establishing and enforcing QA/QC policies, performing root cause analyses, leading corrective and preventive actions, and supporting internal and external audits. The ideal candidate brings deep knowledge of quality standards (such as ISO 9001, ISO 13485, CSA), proven experience in technical environments, and exceptional analytical and communication skills.

This full-time, permanent role is based in Mississauga, ON, with occasional travel required. The successful candidate will play a critical role in shaping a culture of quality, supporting the organization’s reputation for excellence in the Canadian medical technology sector.

What you’ll do: This role is responsible for a variety of functions that include, but are not limited to:

• As a subject matter expert in quality systems, develop and implement a system to allow the service department and the business to standardize its processes.
• Ensure product quality specifications are in compliance with corporate and industry’s standards and requirements.
• Establish QA/QC policies and standards for the Service department and for the business.
• Coach and assist the service team and the other business players to implement and enforce QA/QC policies.
• Lead and execute advanced inspections, testing, and verifications across all Service’s and other department activities.
• Develop and refine QA/QC procedures, checklists, and documentation frameworks to support evolving service and business needs.
• With the assistance of the Regulatory responsible, conduct root cause analysis and lead corrective/preventive action initiatives for high-impact non-conformances.
• Collaborate with cross-functional teams to integrate quality into design, commissioning, and service delivery processes.
• Support internal and external audits, including suppliers and Health Canada inspections.
• Ensure calibration and maintenance of inspection tools and equipment to uphold testing integrity.

Requirements: The successful individual will possess the following skills and qualifications:

• Diploma or degree in Quality Assurance, or a related technical discipline.
• 5+ years of progressive experience in QA/QC roles within a technical, industrial, or manufacturing environment.
• Good knowledge of quality standards and regulatory frameworks (e.g., ISO 9001, ISO 13485, CSA).
• Proven experience in leading inspections, audits, and quality initiatives across diverse technical scopes.
• Strong analytical, documentation, and communication skills.
• Proficiency in QA/QC software, reporting tools, and inspection technologies.
• Ability to work independently and influence cross-functional teams.

Qualifications:

• Diploma or degree in Quality Assurance, or a related technical discipline.
• 5+ years of progressive experience in QA/QC roles within a technical, industrial, or manufacturing environment.
• Good knowledge of quality standards and regulatory frameworks (e.g., ISO 9001, ISO 13485, CSA).
• Proven experience in leading inspections, audits, and quality initiatives across diverse technical scopes.
• Strong analytical, documentation, and communication skills.
• Proficiency in QA/QC software, reporting tools, and inspection technologies.
• Ability to work independently and influence cross-functional teams.

Working Conditions

• Office, Service Centre, Warehouse environment.
• Driving to customers’ locations (healthcare customers’ facilities) may be required.
• Occasional overnight travel may be required.
• Occasional airfare travel may be required.
• Candidate must have valid driving license and passport.

Preferred Skills & Certifications

• Certification in quality or inspection (e.g., CQE, CQT, NDT Level II, ISO Lead Auditor).
• Familiarity with digital QA/QC platforms and data analytics tools.

What’s in it for you:

• Facility in Mississauga close to 401 and/or 407
• Diverse and dynamic teams with challenging and exciting work
• An opportunity to have a real impact on our business.
• A great range of social activities
• Employee referral program
• And so much more!!

Hours and Locations:

• 8:00 am to 5:00pm
• Mississauga (Meadowvale area)
• Hybrid

Note: The successful candidate must be eligible to work in Canada and will be subject to a background check and references.

This job posting is a new vacancy

We rely on people, not algorithms. Our recruiters personally review every application no AI screening is used at any stage.

In accordance with the Accessibility for Ontarians with Disabilities Act (AODA) 2005, should you require any accommodation during the recruitment process, please indicate this on your application and we will gladly work with you to meet your accessibility needs.

If you are interested in working for a progressive and dynamic company with solid growth potential, in a field that has a direct impact on the lives of our employees, hospital staff and patients, we would like to hear from you on how you can contribute and grow with us!

Job Types: Full-time, Permanent

Pay: $68,000.00-$85,000.00 per year

Benefits:

• Company events
• Dental care
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• RRSP match
• Vision care

Application question(s):

• Which quality standards or regulatory frameworks (e.g., ISO 9001, ISO 13485, CSA) are you familiar with, and how have you applied them in your previous roles?
• Describe your experience leading inspections, audits, or quality initiatives. Include examples of projects, scope, or outcomes.
• Which QA/QC software, reporting tools, or inspection technologies are you proficient in? Please describe your level of experience with each.

Work Location: Hybrid remote in Mississauga, ON L5N 5S2