SciCan is a market leader in the manufacture and distribution of dental and medical equipment. SciCan's manufactured sterilization and disinfection equipment is sold in over 80 countries, worldwide. SciCan 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
- Computer skills; MS Office, Visio, PLM & ERP (SAP preferred), QMS Software
- Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery
Additional Information
We offer :Competitive compensation, comprehensive Benefit & Pension program, continuing education reimbursement program, Fun & Positive team environment, a subsidized cafeteria, and free parking to name a few. You may learn more about SciCan business and products by visiting our website at www.scican.com.
We thank all candidates for their interest in SciCan. Candidates that meet the above requirements will be contacted for an interview. No phone calls please.
By applying and submitting your resume to our job posting, candidate acknowledges and confirms that the submitted resume is true and that the candidate is able to provide evidence of academic achievement or other information as required.
SciCan 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.
Join our team of dedicated professionals where your expertise will contribute to innovative manufacturing solutions! Interested candidates please email a copy of your resume to [email protected].
Job Type: Full-time
Pay: From $75,000.00 per year
Benefits:
- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Discounted or free food
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Tuition reimbursement
- Vision care
Ability to commute/relocate:
- North York, ON M3B 3P9: reliably commute or plan to relocate before starting work (preferred)
Application question(s):
- Are you legally eligible to work in Canada?
Willingness to travel:
Work Location: In person
