Quality Engineer (QE)
Location: Sudbury, ON
Job Type: Full-time
Work Arrangement: on-site
About the Role
We are seeking a Quality Engineer (QE) with 2–4 years of experience to support and strengthen quality, compliance, and continuous improvement activities in a regulated healthcare-related operational environment.
This is a hands-on role where quality engineering, data analysis, inspection oversight, and process improvement directly impact operational performance and service quality. The successful candidate will work closely with Operations, Engineering, and Leadership and will be expected to be visible on the floor, engaged with processes, and data-driven in decision-making.
What Success Looks Like in the First 6–12 Months
- Obtain MDRAO certification within the first 6 months (required)
- Stabilize quality data collection, reporting, and KPI tracking
- Independently lead RCA and CAPA activities for assigned issues
- Improve consistency and usability of SOPs and Work Instructions
- Establish effective use of control charts for key processes
- Build strong working relationships with Operations and frontline staff
Key Responsibilities
Quality Systems & Compliance
- Support and improve the Quality Management System (QMS) in alignment with ISO 9001 and CSA
- Participate in internal audits, third-party audits, and regulatory inspections.
- Ensure quality documentation, records, and forms are accurate, current, and controlled.
Data Collection, Analysis & SPC
- Collect, enter, validate, and maintain quality and operational data.
- Analyze data to identify trends, variation, nonconformances, and improvement opportunities.
- Develop and interpret charts.
- Prepare dashboards, KPI reports, and summaries for leadership review.
- Ensure data integrity, traceability, and proper record retention.
RCA & CAPA
- Lead or support investigations related to nonconformances, inspection failures, and audit findings.
- Apply RCA tools such as 5-Why, Fishbone, and 8D.
- Develop, implement, document, and verify the effectiveness of CAPAs.
Inspection & Process Control
- Support incoming, in-process, and final inspection activities.
- Define inspection criteria, sampling plans, and acceptance requirements.
- Analyze inspection results and escalate recurring or systemic issues.
- Support calibration, inspection records, and traceability requirements.
Risk Management
- Support risk-based approaches using FMEA and process risk assessments.
- Link SPC, inspection, and nonconformance data to risk mitigation actions.
Process Improvement & Documentation
- Support continuous improvement initiatives using Lean or Six Sigma principles.
- Develop, review, and update SOPs and Work Instructions with process owners.
- Manage document control activities, including revision, approval, distribution, and archiving.
- Participate in process mapping, workflow analysis, and time studies.
Collaboration & Communication
- Work closely with different stakeholders such as Operations, Leadership, Training teams, etc.
- Support onboarding and training related to quality processes, inspections, and documentation.
- Communicate clearly and effectively with technical and non-technical stakeholders.
Qualifications
Required
- Bachelor’s degree in Engineering, Quality, or a related field.
- 2–4 years of experience in a Quality Engineer or Quality Assurance role.
- Hands-on experience with RCA, CAPA, inspections, and control charts.
- Experience with quality data collection, analysis, and reporting.
- Strong analytical, documentation, and organizational skills.
- Proficiency with Microsoft Excel and quality/statistical tools.
- Strong written and verbal communication skills.
- Commitment to obtain MDRAO certification within the first 6 months of employment (required).
Assets
- Experience in healthcare, medical services, MDRD, or other regulated industries.
- Familiarity with ISO 9001 and CSA standards.
- Exposure to Lean, Six Sigma, or continuous improvement tools.
- PMP (Project Management Professional) certification.
- ASQ Certified Quality Engineer (CQE) certification.
What We Offer
- Support to obtain MDRAO certification
- Meaningful, hands-on quality engineering work with real operational impact
- Exposure to audits, SPC, RCA, CAPA, and inspections
- Clear opportunity for growth into Quality Leadership roles
- Supportive leadership
Job Type: Full-time
Pay: $65,000.00-$85,000.00 per year
Benefits:
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Work Location: In person
