Quality Assurance Lead, Compliance and Audit

6 days ago

Boisbriand, Canada Kinova Full time

Reporting to the Manager, Quality Assurance, you will be responsible for ensuring the effectiveness and compliance of the quality system with regulatory standards.

You will be responsible for implementing processes, forms and policies related to the Quality Management System (QMS).

**MAIN RESPONSIBILITIES**:
Quality system processes:

- Implement the company's quality policy, consistent with the corporate strategy;
- Ensure the conformity of our processes to external requirements and ensure the maintenance of current and future certifications;
- Participate in the development of Kinova's processes and write the procedures/requirements of the quality department;
- Ensure the adequacy and compliance of activities with our procedures and requirements;
- Collaborate with cross-functional teams to resolve quality issues and improve related processes;
- Implement and monitor quality indicators for the various processes; Implement action plans to achieve objectives; Collect quality data for periodic quality review and for Quality Board members;
- Identify and monitor regulations applicable to Kinova's products;
- Lead and optimize the training management process as it relates to quality.

Audit and compliance:

- Evaluate compliance of Kinova's operational activities with ISO 13485: 2016, MDR, FDA, Health Canada, customer requirements and all other applicable product regulations;
- Ensure the planning of internal audits, certification audits and customer audits, supervise the auditors and execute the audits (lead auditor);
- Develop and improve the internal audit process and tools;
- Adopt a risk-based approach to audit program management and corrective action guidance;
- Support the identification of corrective actions;
- Develop the action and verification plan following audits;
- Act as a resource person for other departments in the development of root cause analysis and identification of corrective actions related to processes.

POSITION REQUIREMENTS
- Bachelor's degree or equivalent experience;
- Minimum 7-10 years of professional experience in quality system maintenance;
- Knowledge of ISO 13485:2016, MDR 2017/745,21 CFR part 7, 21 CFR part 11, 21 CFR part 801, 21 CFR part 803, 21 CFR part 806, 21 CFR part 807, 21 CFR Part 820 and DORS/ 98-282;
- Quality systems audit certifications;
- Excellent oral and written communication skills;
- Strong sense of self-reliance;
- Proficiency with computer software;
- Bilingualism (English and French);
- Strong leadership skills.

ASSETS
- Knowledge of ISO 9001: 2015.

WHAT WE OFFER
- Teleworking;
- Competitive salaries;
- Group RRSP with employer contribution;
- Group insurance paid at 50% by Kinova;
- Stable schedule;
- Up to 4 weeks of vacation;
- Personal days off in addition to vacation;
- Snacks, coffee, and fresh fruit at all times;
- A dedicated and great work team;
- A state-of-the-art environment;
- A company culture focused on the development of each individual;
- Free parking;
- Electric vehicle charging stations;
- Regular social and sporting events;
- And much more, but you'll have to meet us to learn more...

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