Quality Assurance Manager

We are a small, ISO-registered, medical device manufacturer located in North York. We are looking for a Quality Assurance Manager to manage our QMS and maintain compliance with ISO 9001 / 13485 / European Union’s Medical Device Regulation.
**Position**:
Quality Assurance Manager
**Reports to**:
President
**Status**:
Full-time position
**Salary**:
Commensurate with experience
**Responsibilities**:
- Maintain the Quality Management System
- Administer the Quality Management System according to FDA, ISO 13485, ISO 9001 standards
- Manage document control activities
- Chair MRB to manage and investigate NCR’s, maintain integrity / traceability of materials
- Approve CAR’s and SCAR’s for non-conformities
- Manage Corrective and Preventative Actions (CAPA)
- Prepare for ISO audits and ensure corrective actions are implemented
- Responsible for product verification and validation
- Responsible for validation protocols and implementation of validation plans
- Develop Quality Objectives continuously and review annually to improve QMS compliance and product quality
- Develop QC test protocols and test products and components as required
- Responsible to implement Quality System and the development of forms, test procedures and work instructions
- Devise and implement quality systems / procedures that provide continuous improvement methodology supporting manufacturing and operational consistency
- Ensure compliance with FDA, ISO and MDR requirements
- Participate in FMEA
- Other quality assurance related duties as required
**Qualifications**:
- Bachelor’s degree in Engineering or Science
- Minimum 5 years of experience in Quality Management (ISO 9001 and ISO 13485 preferred)
- Experienced in Regulatory Affairs (FDA, Medical Device Canada, EU - MDR)
- Experienced in management and able to lead quality team
- Experienced in project management
- Proficient in Microsoft Excel, Word (use of Visio would be an asset)
**Job Types**:
Full-time, Permanent
Additional pay:
- Bonus pay
**Benefits**:
- Casual dress
- Dental care
- Extended health care
- Life insurance
- On-site parking
- RRSP match
- Wellness program
Schedule:
- Day shift
- Monday to Friday
Ability to commute/relocate:
- North York, ON M3A 1B7:
reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Language**:
- and write English fluently (required)