Quality Assurance Manager

Medline Canada, Corporation; Mississauga; On-site; CAD 115,000 - 172,000; Full time

Job summary

Medline Canada, Corporation seeks a Manager, QA to oversee quality and regulatory compliance for applicable products and processes. The role adapts departmental plans and priorities to address resource and operational challenges.

The position requires a BSc in Engineering, Science, or technical field, 4+ years in medical device/drug product quality, and 2+ years of supervisory experience. You will drive improvements, plan validations, and coordinate with internal teams to ensure product quality

Qualifications

• BSc in Engineering, Science, or technical field is required.
• At least 4 years in design/operation of medical device or drug combination product platforms with QSR/GMP/ISO compliance.
• At least 2 years of supervisory/managerial experience preferred in medical device industries (dental, OR/surgical, orthopedic).
• Experience with drug GMPs and regulatory standards (Health Canada, ISO 13485, ISO 14971, MDR).
• Strong data analysis to identify issues and drive improvement.
• Advanced Excel skills including pivot tables and data analysis.

Responsibilities

• Ensure quality and regulatory compliance with Health Canada, drug GMP, ISO across product lifecycle.
• Acts as liaison with US Product Divisions, GSOs, Suppliers, Manufacturing, and L&W to ensure quality products and customer satisfaction.
• Identify and manage execution of continuous improvement projects.
• Assist in product evaluation from a quality assurance/regulatory standpoint; plan design, testing, inspection, and validations to assure quality.
• 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.

Skills

Regulatory compliance

Data analysis

Project coordination

Leadership

Quality management

Education

BSc in Engineering/Science/Technical Field

Tools

Microsoft Excel

Job description

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.

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 Orthopedic 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 [e-mail].

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.