Quality Manager Production

University Health Network; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading healthcare provider in Mississauga is seeking a Quality and Regulatory professional for a permanent full-time role. The ideal candidate will champion process improvements, manage QA/QC teams, and ensure compliance with global standards in healthcare and medical device production. A minimum of a B. Eng and 3-5 years of relevant experience are required. This role is not remote and comes with personal growth opportunities.

Qualifications

• 3-5 years of experience in healthcare/medical device production.
• Experience working in a cleanroom/controlled environment is an asset.

Responsibilities

• Champion a culture of continuous process improvements.
• Spearhead quality improvement initiatives.
• Develop and implement quality strategies.
• Manage a team of QA/QC personnel.
• Ensure compliance with global regulations and standards.

Skills

Lean Manufacturing

Six Sigma

Continuous Improvement

Management Experience

5S

Operations Management

Production Planning

Production Management

Kaizen

Supervising Experience

Education

B. Eng in engineering or life sciences discipline

QMS Internal or Lead auditor certification

Quality (ASQ) or other certifications

Job description

Department: Quality and Regulatory

Location: 3505 Laird Road Mississauga Ontario

Reports to: Vice-President Quality and Regulatory

Status: Permanent Full-Time

Closing date: November 19 2025

Duties and Responsibilities

• Champion a culture of continuous process improvements using methodologies such as Lean Six Sigma and the latest advances in automation.
• Spearhead quality improvement initiatives to continuously improve quality system and production processes.
• Develop and implement quality strategies that anticipate the future needs of the business to ensure compliant sustainable growth.
• Implement and maintain quality system procedures and work instructions to ensure company compliance with global regulations and standards.
• Ensure the routine maintenance of QMS records and metrics analysis for production-related processes (inspection equipment facilities and environment deviations nonconformances).
• Report to Management on the performance (metrics) of the Quality Management System related to production.
• Manage a team of QA / QC personnel including assigning tasks and monitoring performance.
• Manage production quality control activities such as incoming inspection in-process and final device testing product release and shipping.
• Ensure devices produced under the quality system and their associated records are compliant with required standards regulations and internal specifications prior to product release.
• Initiate track progress and ensure timely closure of product nonconformance reports and deviations.
• Contribute to root cause analysis of product-related issues such as complaints CAPAs deviations and non-conformances.
• Trend product-related quality events such as complaints non-conformances and deviations to provide input to product quality improvement initiatives.
• Monitor and maintain procedures related to product design and change control production processes and validated processes such as sterilization and sterile barrier manufacturing.
• Participate in supplier qualification activities including on site audits.
• Participate in the internal audit program external quality audits and site inspections.
• Perform employee training as needed and ensure training records are maintained for company personnel.
• Participate in design and development activities including design transfer to production and process validation. Ensure that Medical Device Files / Device Master Records are maintained for the companys products.
• Ensure that software used in production processes is validated.
• Other duties as assigned.

Qualifications : Education

• Minimum or B. Eng in engineering or life sciences discipline
• QMS Internal or Lead auditor certification
• Quality (ASQ) or other certifications an asset

Experience

• 3-5 years of experience in healthcare / medical device production
• Experience working in a cleanroom / controlled environment is an asset.

Skills and Knowledge

• Knowledge of a quality improvement methodologies equivalent to Lean and Six Sigma
• Knowledge of ISO 13485 and ISO 14971
• Knowledge of FDA and EU regulations
• GMP- Good Manufacturing Practice
• Competent Written and Oral communication.
• Proven team player with good problem-solving skills.

Additional Information

We thank all applicants for their interest however only those selected for further consideration will be contacted.

Remote Work : No

Employment Type : Full-time

Key Skills

Lean Manufacturing,Six Sigma,Continuous Improvement,Lean,Management Experience,5S,Operations Management,Production Planning,Production Management,Kaizen,Supervising Experience,Manufacturing

Vacancy : 1