Quality Manager

**Job Type**:
Full Time

**Location**:
North York, ON

Date Posted:
2025-02-18

Job ID:
C6509134

**Job Duties & Responsibilities**:

- Perform Supplier audits, qualification and evaluations.
- Provide input to design and development activities, manufacturing, Materials staff on supplier selection criteria, Business Unit platform meetings, and product certification related issues.
- Oversee and facilitate safety test house inspection audits of production facility.
- Oversee incoming inspection, in-process inspection, and final inspection activities.
- Perform statistical analysis of products and services, field data, and supplier performance.
- Assess and test parts returned from the field to determine/validate defect types and assess correlation to in-house failures.
- Drive manufacturing product quality improvements through regular quality control checks, monitoring production failures and customer complaints and engaging with R&D, Production, IE, BU, etc. to resolve issues in a timely manner.
- Drive quality awareness throughout the company and coordinate and lead product quality improvement initiatives with team members and identify root cause(s) and implement solutions and KPIs.
- Develop and implement continual improvement programs.
- Oversee metrology for all tool, jigs and fixtures.
- Review, disposition and approval of customer complaints.
- Monitor and assess monthly complaint reporting and report to management trends and actions.
- Provide leadership developing and directing QA/QC personnel and identify relevant training needs.
- Develop and manage departmental budget.
- Provide direction, guidance, and feedback to all staff, and senior management team on quality programs and initiatives.
- Review and approval of Internal Audit program.
- Review approval of CAPA's resulting from all audits.
- Oversee CAPA program.
- Provide guidance on development of procedures and processes as they relate to the quality management system companywide.
- Work with Industrial Engineering to develop process validation plans.
- Develop Quality Plans and Process Validation reports for manufactured products and perform process validation activities.
- Review Technical files to ensure adherence to ISO 13485 requirements (Input/output, verification /validation, design reviews)
- Act as liaison to notified body and other external certification bodies.
- Oversee/facilitate external audits to ISO standards, FDA Inspections, Health Canada Inspections, Foreign inspections, etc.
- Perform Management Quality Representative Duties, including:

- 1. Chair yearly QMS Management Review
- 2. Sign-off authority for changes to procedures, processes, design (delegated), etc.
- 3. Authority to act on behalf of top management during the audit
- 4. Authority to place products or processes on hold.
- 5. Responsibility for managing quality audit functions (delegated).
- 6. Responsibility for contributing to corrective and preventive action activities, complaint handling and the handling of nonconforming product, etc.

**Educational and Experience Requirements**:

- Degree in Quality Engineering or Engineering Degree plus Quality Certificate.
- Minimum of 5-10 years of experience dealing with quality management systems, regulations, guidelines and associated standards preferably in a Medical Device manufacturing environment preferably with technology related products.
- Knowledge and experience in ISO 13485, MDSAP required; MDR experience is an asset.
- Demonstrated experience in taking companies through required quality management certification processes and audits as the MQR.
- Management of staff in various disciplines in quality management.
- Experience in training and developing personnel at all levels in quality management.
- Must possess excellent communication skills for liaising and communicating with suppliers, customers, auditing bodies, and internal departments.
- Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery.
- Practical experience with risk management, product testing, capability studies, GD&T, and quality plans.
- Ability to create and review technical documentation, including project plans, test procedures, and design documents.