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.
- 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.
