Senior Quality Assurance Engineer

Sci Can is a market leader in the manufacture and distribution of dental and medical equipment. Sci Can's manufactured sterilization and disinfection equipment is sold in over 80 countries worldwide. Sci Can is located in Toronto near the intersection of Highways 401 and 404 (Don Mills and York Mills). It is accessible by public transportation.

We currently have an opening for a Senior Quality Assurance Engineer. This position will be responsible for ensuring compliance with Quality Management System (QMS) requirements, regulatory standards, and internal procedures. This role plays a key function within QA by driving quality improvements, managing various audit activities, supporting cross‑functional teams and projects, and providing training to teams. The position also supports supplier quality, product quality, and process validation activities.

Job Duties & Responsibilities

Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485:2016, MDSAP, and applicable regulations

Review, revise, and release quality documents (SOPs, Instructions, Controlled forms)

Conduct QMS training and ensure training effectiveness

Lead internal audits and support external audits and regulatory inspections

Ensure audit readiness and timely closure of findings

Perform and support investigation activities for CAPAs, complaints, and deviations; ensure timely closure

Perform root cause analysis (e.g., 5‑Why, Fishbone) and implement corrective actions

Execute and support process validations (new and existing processes)

Generate and analyze quality metrics; drive continuous improvement initiatives

Prepare quality reports and support management review

Issue and control quality documents (TDNs, product holds/releases, certifications, CoCs)

Support final and in‑process inspections activities

Manage floor quality controls (e.g., sanitation reports, stamp control)

Manage Quality Plans, including creation, status tracking, and closure

Review and approve test cases and system validations (ETR/ERP)

Partner with R&D, Regulatory, Operations, and Procurement on product compliance and changes

Support onboarding, training, and development of QA team members

Provide backup support across QA functions as needed

Educational and Experience Requirements

Degree in Quality Engineering or Engineering Degree plus Quality Certificate

Minimum of 3 years related experience in a Medical Device manufacturing environment, preferably with technology related products

Extensive familiarity with ISO 13485, preferably the 2016 version; MDSAP experience and application

Experience with Class I & II medical device regulations

Internal auditing and risk management experience assets

Strong communication skills both verbal and written

Ability to work in groups as well as independently with minimal supervision

Strong analytical and problem‑solving skills are essential

Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery

Benefits
Competitive compensation, comprehensive Benefit & Pension program, continuing education reimbursement program, Fun & Positive team environment, a subsidized cafeteria, wellness programs, and free parking to name a few. You may learn more about Sci Can business and products by visiting our website at

Sci Can strongly believes that diversity in the workplace is essential to our success. We are committed to providing equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, disability, gender identity and we are committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA).

Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.

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