Quality Manager - GTA

Getinge•Toronto, ON

4d•CA$97,900 - CA$115,000•Hybrid

About The Position

In our Quality/Regulatory Department we are looking for a Quality Manager. The main function of the Quality Manager is to maintain all aspects of the established Canadian SSU’s Quality Management System in compliance to the applicable ISO standards. They will liaison between the global and local organization to ensure best practices are established and enforced. The Quality Manager will also conduct internal audits, represent the company in third party audits and provide feedback on process improvements. This position maintains and leads all Canadian SSU CAPAs.

Requirements

Bachelor’s degree or equivalent education.
A minimum of seven (7) or more years of experience in quality assurance, quality control or related functions in a FDA/Health Canada regulated industry or ISO certified organization is required.
Demonstrated expertise with quality agreements, negotiations, and metrics/trending analysis.
Knowledge and experience in the application of a Quality Management System and all associated requirements.
Excellent communication and interpersonal skills (oral and written).
Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
Must be able to facilitate teams to drive in the use of critical thinking, problem solving and decisions.
Must have effective problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of Quality System strategies on business performance.
Must have in-depth knowledge of all applicable Quality System Standards.

Nice To Haves

Seven to ten years of related experience managing and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.

Responsibilities

Maintains the implementations of the corporate Quality Management System per ISO 9001 and ISO 13485 standards.
Identify and assess Quality System risks for assigned projects or programs.
Maintains required QMS records.
Create, or assist in the creation of, Standard Operating Procedures to maintain practical, efficient compliance to Getinge’s GetQMS and Global Sales’ Quality Systems requirements.
Represents Getinge to outside parties and supports all third party quality systems inspections and audits.
Performs Internal Audit activities in line with applicable standards.
Maintain applicable KPI’s and reports to management.
Performs all corrective and preventative actions and maintains documentation.
Act as Subject Matter Expert on Quality System processes internally and externally.
Acts as a key driver of change within the organization, supporting peers and leaders by implementing and communicating training requirements and educating team members on how training is a key part of compliance initiatives.
Conduct New Hire Quality System Training and other trainings as needed.
Prepares and facilitates Management Review meetings including all required inputs and follow up action items.
Strengthen Quality Management System awareness, support Sales & Service teams, and process improvements.
Maintains current knowledge base of all QMS related changes within the industry.
Performs other related duties as required or assigned