Atrium Medical

Quality Manager - GTA

Atrium Medical • $97K — $115K *
Mississauga, ON L4T 0A1In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent education.
  • 7+ years in quality assurance/control in a regulated industry.
  • Experience managing Quality Management Systems in medical device or pharmaceutical sectors preferred.
  • Expertise in quality agreements, negotiations, and metrics analysis.
  • Strong communication and interpersonal skills essential.

Responsibilities

  • Maintain compliance with ISO 9001 and ISO 13485 standards.
  • Identify and assess Quality System risks for projects.
  • Create and assist in Standard Operating Procedures for Quality Systems.
  • Represent the company during third-party quality inspections.
  • Perform internal audits based on industry standards.
  • Facilitate Management Review meetings and track action items.
  • Conduct training on Quality Systems for new hires.

Benefits

  • Hybrid work environment with office location in Mississauga.
  • Opportunities for continued professional development.
  • Involvement in significant quality assurance initiatives.
Full Job Description
In our Quality/Regulatory Department we are looking for ...

A Quality Manager

Job Overview

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.

Job Responsibilities and Essential Duties
  • 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


This position will be hybrid. Our office is located in Mississauga, Ontario.

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


Required Knowledge, Skills and Abilities
  • 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.
    Targeted salary range $97,900.00 - $115,000.00 + 15% bonus
    #LI-JF1 #LI-Hybrid

About Atrium Medical

Atrium Medical is a medical device company that develops and manufactures products for cardiovascular, surgical, and other medical applications. The company's products include vascular grafts, endovascular stent grafts, and other devices used in cardiac and thoracic surgery. Atrium Medical was founded in 1981 and has been a subsidiary of Getinge AB since 2011.
Learn more about Atrium Medical
Size
500 employees
Industry
Healthcare
Founded
1904
* Ladders Estimates

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