Quality Manager in Ottawa at Apex Life Sciences

Date Posted: 4/22/2018

Job Snapshot

Job Description


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 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.

Responsibilities:

  • 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.

Required Qualifications:

  • Degree in business, science or engineering.
  • ASQ Certified Manager of Quality certification is an asset but not required.
  • 5-10 Years experience in a Quality Management role, preferably in the Medical Device industry.
  • Experience with ISO13485 and UD-FDA inspections.
  • Leadership 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

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.