Quality Manager

**Quality Manager**
**-**
**(**
**23300940**
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**Description**

Position Summary

The Quality Manager, Canada oversees the quality team and all quality activities performed in the region to ensure that compliance is achieved for all Drug and Device products marketed in Canada. This position is responsible for ensuring compliance with the ICU Quality System, Canadian Drug GMPs, Canadian Medical Device Regulations, ISO13485 and any other applicable international regulations/requirements. This role interacts with Health Canada and any other applicable regulatory agencies during audits and other quality matters as appropriate.

Essential Duties & Responsibilities
- Drive improvement of the Quality System by developing and improving procedures and providing training to ensure compliance requirements are being met for activities carried out in the Canadian market.
- Collaborate and work with Canada commercial leaders to support the business and ensure continued compliance.
- Assist in maintaining the Quality Management System in compliance with ICU quality system and Health Canada regulations and any other applicable regulations and standards.
- Responsible for the oversight and execution of recalls and Field Safety Notices within the Canadian market.
- Responsible for managing the quality function including service and distribution quality personnel located in Canada
- Responsible for the oversight and execution of all activities related to import, release, and distribution of Drug products into Canada in compliance with Health Canada GUIDE-001
- Responsible for the oversight and execution of all activities related to import, and distribution of Medical Device products into Canada in compliance with Health Canada Medical Device Regulations.
- Works hand in hand with key local leaders to establish common goals, objectives, and projects to improve regulatory compliance, product performance, efficiency and overall cost of quality and drives improvement in customer satisfaction and financial results.
- Provide input on quality metrics for areas assigned as presented for Management Review
- Provide strategic direction and oversight for internal and external audits to influence positive outcomes
- As necessary, develop, manage and execute Quality Plans
- Perform these and other duties as assigned

Knowledge, Skills & Qualifications
- Must have knowledge of Drug and Device Canadian regulations and of relevant Quality and Regulatory Compliance discipline.
- Strong Quality Auditing principles
- Team-oriented and able to lead and influence without authority. Team building and collaborative leadership skills are necessary.

Education and Experience
- Bachelor’s degree in sciences or other technical areas
- 10 years of experience in the Medical Products industry to include direct experience with drug products, medical devices and regulatory environments is required
- Experience and successful track record with hosting and or supporting regulatory inspections.

Travel Requirements
- N/A

Physical Requirements and Work Environment
- While performing the duties of this job, the employee is regularly required to talk or hear.
- This job operates in a professional office and warehouse environment.
- This job requires computer work for hours at a time, along with standing and walking.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location***: CA-CA-St. Laurent

**Schedule***: Full-time

**Shift***: Day Job