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Medline

Makes and delivers medical supplies to hospitals

Quality Assurance Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMississauga, ON, CanadaHybrid

About the Job

Requirements

  • A Bachelor of Science degree in Engineering, Science, or a technical field is required.
  • At least 4 years of experience related to the design or operation of medical device or drug combination product platforms, design controls, risk management, and compliance with QSR/GMP/ISO requirements or other regulated industries, including Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR.
  • Experience with drug GMPs.
  • Broad technical knowledge of relevant standards and regulations, including Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR.
  • Proficiency in analyzing and reporting data to identify issues, trends, or exceptions, drive improvement of results, and find solutions.
  • Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines.
  • Advanced Microsoft Excel skills, such as using the AVERAGE function, merging and centering cells, printing a centered page, or creating a pivot table.

Responsibilities

  • Manage quality and compliance for applicable products and processes, adapting departmental plans and priorities to address resource and operational challenges.
  • Ensure quality and regulatory compliance with applicable regulations, such as Health Canada, drug GMP, and ISO, for the applicable product lifecycle and regions of distribution.
  • Act 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 with product evaluation from a quality assurance and regulatory compliance standpoint.
  • Assist in planning 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 product or production quality issues by interfacing with internal and external customers.

Desired Qualifications

  • At least 2 years of supervisory or managerial experience is preferred.
  • Experience in the medical device industry, specifically dental, operating room/surgical instruments, or orthopaedics, is preferred.

About the Company

Medline

Makes and delivers medical supplies to hospitals

Medline makes and distributes medical and surgical supplies for hospitals, surgery centers, nursing homes, physician offices and other care sites. It runs its own factories alongside a large network of warehouses and delivery routes, so one company can produce exam gloves, gowns and surgical kits and then deliver them straight to the bedside. Many health systems sign multi-year prime vendor agreements that make Medline the source for most of their medical-surgical supplies. It earns money selling its own products and those of other manufacturers, together with supply chain services. Medline was founded in 1966 and is based in Northfield, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Northfield, IL
Founded
1966

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