QA/ra Specialist

**Job Title**: Quality Assurance and Regulatory Affairs Specialist

**Location**: Vaughan or Oshawa, ON

Pacific Surgical Holdings Ltd. is a family of dynamic healthcare companies focused on manufacturing, sales and service of medical devices operating from locations throughout North America. We are committed to bringing progressive products and service solutions to our customers in Canada and around the globe. Our company is dedicated to delivering high-quality products and services that meet regulatory standards and exceed customer expectations.

We are seeking a detail-oriented and motivated individual to join our team as a Quality Assurance and Regulatory Affairs Specialist for full-time employment. In this role, you will play a crucial part in ensuring that our products and services adhere to regulatory requirements and meet the highest quality standards. You will work closely with the Quality Assurance/Regulatory Affairs, Technical and Operation teams from multiple divisions across Pacific Surgical group of companies to support the maintenance of quality management systems (QMS) to ensure compliance with quality and regulatory standards such as ISO 9001, ISO 13485, Medical Device Regulations of Canada (SOR 98-282) and US (FDA CFR 820).

**Responsibilities**:

- Conduct document control activities, including preparing, reviewing, distributing, training, filing and archival of controlled documents.
- Participate in internal and external audits, including preparation, execution, and follow-up activities.
- Assist with the investigation, root cause analysis and reporting of non-conformities.
- Developing, implementing and measuring effectiveness of corrections, corrective actions and preventative actions and other continual improvement measures.
- Support in the review and renewal of medical device licences and medical device establishment licences.
- Support supplier qualification activities.
- Collaborate with cross-functional teams to address quality and regulatory issues and drive continuous improvement initiatives.
- Support with post-market surveillance activities in monitoring medical device recalls and alerts, measuring customer feedback and facilitating and reporting customer complaints
- Participate and assist with the Occupational Health and Safety programs
- Various tasks as specified by the QA/RA Manager.

**Qualifications**:

- Excellent interpersonal and communication skills, with the ability to work effectively in a team and collaborate with internal and external stakeholders.
- Ability to diplomatically handle conflicts and resolve regulatory or quality-related concerns.
- Minimum one year experience in quality assurance and regulatory affairs is preferred.
- Bachelor’s degree in a relevant field (e.g., Health Sciences, Public Health, Biomedical Engineering, or Regulatory Affairs).
- Some knowledge in ISO 9001, ISO 13485, MDSAP, ISO 14971, FDA CFR 820 or SOR 98-282 is preferred.
- Strong organizational and analytical skills with the ability to manage multiple projects simultaneously

**Job Types**: Full-time, Permanent

Pay: $60,000.00-$70,000.00 per year

**Benefits**:

- Commuter benefits
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Profit sharing
- RRSP match
- Vision care

Ability to commute/relocate:

- Vaughan, ON: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- Bachelor's Degree (required)

**Experience**:

- ISO: 1 year (preferred)
- Quality assurance: 1 year (preferred)

**Language**:

- French (preferred)

Work Location: In person