Quality Manager - Medical Device
Apex Life Sciences is searching for a Quality Manager for a permanent role in one of our client companies. Our client is a medical device/ biotech company based in the Ottawa, Ontario region. This position would be responsible for the management and maintenance of the Quality Management System and responsible for a team of direct reports. Candidates with continuous improvement experience, experience working with contract manufacturing organizations and a strong track record of working with external auditors are desired.
This position has a competitive salary and benefits package.
- Lead all Quality Assurance activities for the site.
- Management of Corrective Action and Preventative Action (CAPA) process.
- Lead Continuous Improvement initiatives.
- Management of the internal audit program.
- Management of the Document Control system.
- Supplier qualification, supplier audit, monitoring of supplier performance metrics.
- Investigation of customer complaints and product returns.
- Monitor KPIs to assess organizational performance.
- Participation in New Product Introductions and Product Changes.
- Drives Quality By Design for NPI - leads design reviews.
- Reviews validation plans and reports.
- Manage and guide implementation of QMS software.
- Responsible for leading a team of 6-8 employees.
- Team performance and metrics.
- Degree in business, science or engineering.
- ASQ Certified Manager of Quality certification is an asset but not required.
- 5+ Years experience in a Quality Management role, preferably in the Medical Device industry.
- Experience with ISO13485 and UD-FDA inspections.
- Leavership and development experience.
- Excellent time management skills, communication skills and problem solving skills.
- Demonstrated success in achieving quality objectives.
- Previous experience with supplier quality management programs