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Quality Assurance Manager

3 weeks ago

North York, Canada SciCan Full time

**Job Summary**:
The Quality Assurance (QA) Manager ensures that quality standards and policies &procedures are upheld and aligned with regulations and customer specifications. This individual is responsible for managing the organizations quality assurance programs and being directly involved in the new product development processes. The QA Manager will help establish and implement process improvements to increase the efficiency, effectiveness, and quality of the company's operations and products. Other responsibilities will include the supervision of the Quality Department personnel, leading product quality improvement initiatives, supporting customers’ needs, and overseeing the company’s Quality Management System in the role of Management Quality Representative.

**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 SciCan's 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 to Sci Can 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 SciCan 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.
- Maintain SciCan's ISO 13485 certification, and all other required standards.
- 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 p