Compliance coordinator, auditor

As a compliance coordinator, auditor, you will be responsible for ensuring the compliance of the quality system through internal audits and by monitoring the data from the different processes of the system. Your quality system expertise and leadership will be used to support the different teams within the company.

 

Main responsibilities

  • Assess the conformity of Kinova's operational activities to the requirements of ISO 13485:2016, ISO 9001:2015, MDR, FDA, Health Canada, customer requirements, and any other regulations applicable to the products;
  • Develop and improve the internal audit process and tools;
  • Planning and ensuring the completion of internal audits;
  • Ensure the supervision of auditors;
  • Adopt a risk-based approach in managing the audit program and directing corrective actions;
  • Ensure the preparation of certification audits and client audits;
  • Coordinate the development of action and audit plans following audits;
  • Train all new employees on the quality system;
  • Support the identification of corrective actions;
  • Act as a resource person for other departments for the development of root cause analysis and identification of corrective actions;
  • Implement and monitor quality indicators.

Requirements

  • University degree or equivalent experience (engineering degree an asset);
  • Auditor certification (an asset);
  • Three to five years of professional experience in compliance and internal audit;
  • Knowledge of ISO 9001:2015, ISO 13485:2016, MDR 2017/745, 21 CFR Part 820, 21 CFR Part 11, SOR 98-282;
  • Ability to take a step back and have a strategic vision;
  • Excellent interpersonal communication;
  • Ability to work with little supervision;
  • Excellent command of Google Suite and Office;
  • Bilingual, French, and English (written English);
  • Confirmed leadership and ability to influence.

Starting date

  • As soon as possible

What we offer

  • Snacks, coffee, and fresh fruits at all time;
  • Devoted and formidable work team;
  • Cutting edge technology work environment;
  • Company culture focused on the active development of each individual;
  • Personal days offs, in addition to vacation;
  • Competitive salaries;
  • Group insurance;
  • Free parking;
  • Charging stations for electric vehicles;
  • Regular social and sports activities;
  • And even more! But you'll want to meet us to know further...

Contact information

Education - Competence

Other information

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