QA Manager

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

Benefits offered by this job

Education support programs

Home office reimbursement

Employee referral program

Paid vacation and personal days

Annual employee appreciation week

EAP — Employee Assistance Program

Job summary

Medline Canada is seeking a Manager of QA to lead quality and regulatory compliance across applicable products and processes. You will coordinate with internal and external partners to drive improvements, evaluate products from a QA/regulatory perspective, and resolve issues promptly.

The role requires a BSc in a technical field, 4+ years in medical device or drug products, familiarity with Health Canada/ISO/GMP standards, and a track record of supervisory responsibilities.

Qualifications

• BSc required in Engineering, Science, or Technical Field.
• 4+ years in design/operation of medical device or drug combination product platforms with design controls and risk management.
• Experience with GMP/ISO requirements (Health Canada, ISO 13485, ISO 14971, MDSAP, MDR).
• 2+ years supervisory/managerial experience preferred.

Responsibilities

• Ensure quality and regulatory compliance with Health Canada, drug GMP, ISO for product lifecycle and distribution regions.
• Act 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 QA/regulatory standpoint; plan design/testing/inspection and validations.
• Resolve quality issues to customer satisfaction in a timely manner.
• Other duties as assigned.

Skills

Data analysis

Quality assurance

Regulatory compliance

Project coordination

Excel advanced

Education

BSc in Engineering/Science/Technical Field

Tools

Microsoft Excel (Pivot Tables)

Job description

Value PropositionAs 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 employeesMarket competitive compensation and benefits plan, including LTD & InsuranceRRSP with a company matchAnnual Employee Appreciation WeekPaid vacation and personal daysEmployee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-beingCareer growth and training programsOpen communication with Senior LeadersTailored incentives for eligible employee groups, such as home office reimbursementEmployee referral programEducation support programsFitness subsidyRecognition programsSocial activitiesAnd much more…Job Description SummaryThe 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 DescriptionResponsibilities: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.undefinedQualifications: 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 preferredExperience 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 AnnualThis 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 CanadaMedline 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 InclusivityMedline 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 AccessibilityMedline 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] qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.