Quality Assurance & Post Market Specialist- Global Medical Device Company

Summit has partnered with a leading global medical technology company in their hunt for a Quality Assurance & Post Market Specialist!

This individual must serve as a contributing member of the QA team while championing the companies’ Mission and Values.

Responsibilities

Individual Responsibilities:

  • Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation

Functional Responsibilities:

  • Conduct product incident follow up, including filing necessary reports with manufacturers and Health Canada in accordance with the Medical Device Regulations
  • Coordinates voluntary recalls in accordance with the Medical Device Regulations
  • Monitor customer complaints for adverse trends and analyze data to identify opportunities to reduce complaints and improve customer satisfaction
  • Support the Quality Management System and operate as a resource for the ISO 9001 Standard
  • Participate in Third Party Audits and follow up on Corrective Actions
  • Coordinate the document control process by ensuring change control and record retention requirements are met.
  • Liaise with Corporate Quality Managers on behalf of the company
  • Work with all areas within the company (Sales, Operations, and Marketing)
  • Work with all regulatory affairs and quality assurance personnel at all manufacturing sites
  • Builds good rapport with Health Canada
  • Other duties as assigned by Manager

Conduct & Compliance

  • Abide by and support the policies set forth in the company code of conduct
  • Understand that compliance with the Code of Conduct
  • Conduct work in compliance with all laws, rules, and regulations and in accordance with the companies’ high ethical standards
  • Report any violations of these policies and procedures to the company

Knowledge & Skill Requirements

  • Working knowledge of Canadian Medical Device Regulations and ISO 9001 Standard
  • Strong computer skills (Excel, Word, Power Point, Share point)
  • High standard of integrity and ability to meet deadlines
  • Highly organized and able to prioritize tasks
  • Strong oral and written communication skills with both internal and external contacts
  • Ability to make and support decisions with regards to regulatory and quality issues

 

Education & Qualifications

  • University Degree required
  • Post-graduate diploma in Regulatory Affairs or Quality Assurance Preferred (completed or in-process)
  • At least one year of experience in a regulatory affairs and quality assurance environment an asset

Summit Search Group is a fair and equitable search firm. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the recruitment and selection process.

Job ID

SP021619

City

Hamilton, ON

Remuneration

Recruiter

Categories:    Operations    Other   

Apply Online

If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.

Position Applying For:

Quality Assurance & Post Market Specialist- Global Medical Device Company

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