Quality Management System (QMS)/QA Intern
Location: Remote (Canada), Calgary preferred
Duration: 3-6 months
About MHCombiotic
MHCombiotic is a Canadian company focused on developing novel antimicrobial wound care solutions designed to improve patient outcomes and address challenges associated with wound infections and biofilms. As we prepare for our upcoming surveillance audit, we are seeking a motivated Quality Management System (QMS) Intern to support audit readiness, quality assurance, and continuous improvement activities.
Position Summary
The QMS Intern will support the maintenance of the Quality Management System (QMS) in accordance with ISO 13485, MDSAP, and applicable medical device regulations. A key focus of this role will be supporting the company's ISO 13485 and MDSAP Surveillance Audit taking place in August 2026, including audit preparation, document review, records management, evidence compilation, and audit readiness activities. The intern will also assist with SOP updates, CAPA activities, and other quality system initiatives.
Key Responsibilities
- Support surveillance audit preparation activities, including document review and audit evidence collection.
- Assist with CAPA (Corrective and Preventive Action) investigations, tracking, and effectiveness checks.
- Review and update Quality Management System documentation to ensure compliance with ISO 13485 and MDSAP requirements.
- Assist with the development, revision, and formatting of Standard Operating Procedures (SOPs), forms, work instructions, and quality records.
- Support the management of nonconformities, deviations, and quality events.
- Participate in internal audits and help track audit findings and follow-up actions.
- Assist with document control activities, including version control and record management.
- Support supplier quality and quality metrics tracking as required.
Qualifications
Required
- Canadian citizen/PR
- Completed a degree in: Life Sciences, Biomedical Sciences, Biotechnology, Pharmacy, or a related scientific discipline
- Audit leading/participation experience
- Strong knowledge of ISO 13485, MDSAP, SOR 98/282, 21 CFR and medical device quality systems.
- Exposure to CAPA processes, nonconformity management, risk management, or internal audits
- Previous internship, co-op, research, or industry experience in quality assurance, regulatory affairs, or medical devices
- Strong understanding of Quality Management Systems and quality documentation.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Assets
- Quality or regulatory certifications (e.g., ISO 13485, Quality Assurance, Internal Auditor training).
What You'll Gain
- Hands-on experience supporting an ISO 13485-certified medical device Quality Management System.
- Exposure to MDSAP surveillance audit preparation and quality compliance activities.
- Experience working with CAPAs, nonconformities, SOP development, document control, and internal audits.
- Mentorship from professionals in medical device quality and regulatory affairs.
- Opportunity to contribute to the development and commercialization of innovative wound care technologies.
How to Apply
Please send your resume and a cover letter to [email protected]Subject line: Application - Quality Management System (QMS)/QA Intern
We thank all applicants for their interest; however, only those selected for an interview will be contacted
Pay: $2,500.00-$5,000.00 per month
Work Location: Hybrid remote in Calgary, AB T2L 2E5
