QA Manager

Posted 2 Days Ago
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Mississauga, ON, CAN
In-Office
115K-172K Annually
Mid level
Other
No.1 privately held manufacturer & distributor of health care products in the U.S.
The Role
Manages quality assurance and regulatory compliance for medical device and drug combination products. Coordinates with product divisions, suppliers, manufacturing, and other stakeholders to ensure product quality and customer satisfaction. Leads continuous improvement initiatives, product evaluations, testing, inspections, process validations, and quality issue resolution. Requires technical expertise in Health Canada, GMP, ISO, medical device regulations, design controls, risk management, data analysis, project coordination, and advanced Microsoft Excel.
Summary Generated by Built In

Value Proposition
As a leading partner in healthcare, Medline Canada's sole purpose is to make healthcare run better – this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. We employ a diverse group of top talent focused on growing and making a difference in the lives of Canadians, coast-to-coast.
Compensation is only one part of the Employee Value Proposition that Medline Canada offers our employees. As part of our mission, we offer one of the most competitive and engaging employee experience programs in Canada, which includes:
 

  • Collaborative work environment with highly engaged employees

  • Market competitive compensation and benefits plan, including LTD & Insurance

  • RRSP with a company match

  • Annual Employee Appreciation Week

  • Paid vacation and personal days

  • Employee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-being

  • Career growth and training programs

  • Open communication with Senior Leaders

  • Tailored incentives for eligible employee groups, such as home office reimbursement

  • Employee referral program

  • Education support programs

  • Fitness subsidy

  • Recognition programs

  • Social activities

  • And much more…

Job Description Summary

The Manager, QA is responsible for managing the quality and compliance for applicable products and processes. This role adapts departmental plans and priorities to address resource and operational challenges.

Job Description

Responsibilities:

  • Ensure quality and regulatory compliance with applicable regulations (ex. Health Canada, drug GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
  • Acts as a liaison with US Product Divisions, GSOs, Suppliers, Manufacturing, and/or L&W to ensure quality products and customer satisfaction.
  • Identify and manage the execution of continuous improvement projects.
  • Assist Medline Canada in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
  • Assist in resolving quality issues to customer satisfaction, in a timely manner.
  • Resolve issues relating to product or production quality by interfacing with internal and external customers.
  • Other duties as assigned.
  • undefined

Qualifications:

  •  BSc required in Engineering, Science, or Technical Field.       
  • At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR).
  • At least 2 years of supervisory/managerial experience preferred.·        Experience in Medical Device Industries - Specifically dental, OR/Surgical Instrument or Orthopaedic preferred
  • Experience with drug GMPs.      
  • Broad technical knowledge of relevant standards and regulations (Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR etc.)·        Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.       
  • Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.·       
  • Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

The anticipated salary range for this position:

$114,600.00 - $171,800.00 Annual

This job description is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization.

Medline Canada, Corporation is proud to be an equal opportunity employer.

About Medline Canada
Medline Canada stands at the forefront of healthcare, providing expertise and a breadth of solutions for every care setting. With 550+ employees, including 100 dedicated sales and clinical professionals and eight distribution centres located coast-to-coast, Medline Canada is proud to serve the entire continuum of care.
Our Commitment to Diversity and Inclusivity
Medline Canada is committed to diversity and inclusivity and we encourage applications from members of groups that have been historically disadvantaged and marginalized, including First Nations, Metis and Inuit peoples, Indigenous peoples of North America, racialized persons/persons of colour and those who identify as women, persons with disabilities and LGBTQ+ persons.
Our commitment to Accessibility
Medline Canada is committed to the principles of the accessibility in Canada. We endeavor to make our recruitment, assessment and selection processes as accessible as possible and provide accommodations as required for applicants with disabilities. If you require any accommodations at any point during the application and hiring process, please contact [email protected].
All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.

Skills Required

  • Bachelor of Science degree in Engineering, Science, or a technical field
  • At least 4 years of experience related to medical device or drug combination product design or operation
  • Experience with design controls and risk management
  • Experience complying with QSR, GMP, ISO, Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR requirements
  • At least 2 years of supervisory or managerial experience
  • Experience in the medical device industry, especially dental, orthopedic, or surgical instruments
  • Experience with drug GMPs
  • Broad technical knowledge of relevant standards and regulations
  • Ability to analyze and report data to identify issues, trends, and exceptions
  • Ability to coordinate concurrent projects, competing priorities, and critical deadlines
  • Advanced Microsoft Excel skills, including pivot tables and spreadsheet formatting
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The Company
HQ: Northfield, IL
20,000 Employees
Year Founded: 1961

What We Do

All across America and the world, we help healthcare systems improve patient outcomes and reduce costs through clinical and financial solutions. As both a manufacturer and distributor of medical devices and supplies, we’re made up of problem solvers. Risk-takers. Big thinkers and doers.

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