Quality Assurance Coordinator

**Quality Assurance Coordinator Job Description**

**Job Title**:Quality Assurance Coordinator, SBI Alapharma Canada Inc.

**Reporting**:Reports to the Project Manager, SBI ALApharma Canada Inc.

**General Summary**

The incumbent will embrace the SBI ALApharma Canada Inc. core values:

- Merit
- and performance-based recognition and advancement.
- Build value for customers and investors.
- Innovation without ego.
- Relentlessly seek continuous improvement opportunities.
- Achieve results with a sense of urgency.
- Find how we can, not why we can’t.
- We value a profitable growing company; growth creates opportunities, profit allows pursuit of opportunities.
- We are intolerant of bureaucracy that adds no value to our customers.

**JOB **SUMMARY**

The Quality Assurance Coordinator will support the implementation and maintenance of SBI ALApharma Canada’s Quality Management System. This includes being an advocate for maintaining the effectiveness of the quality management system, ensuring product realization is occurring according to the prescribed processes, and continuously monitoring, measuring, and improving processes.

**DUTIES AND RESPONSIBILITIES**:

- Support the continuous maintenance of the company’s quality management system to the ISO 13485 (MDSAP CAN, USA) requirements.
- Assist in expanding the current quality management system as required for new jurisdictions and/or regulatory requirements.
- Perform project phase audits, internal audits, and supplier audits to verify compliance to requirements.
- Participate in design reviews and design transfer activities at various design and development stages.
- Verify traceability of design and development outputs to design and development inputs.
- Review, control, publish, and maintain documents and records.
- Follow-up on issues of non-compliance (corrective actions, non-conforming product, problem reporting) and verify closure.
- Monitor and facilitate periodic reviews of customer feedback and change requests.
- Assist with providing training to other employees on quality management system processes.
- Provide support and participate in the development of regulatory filings and submissions.
- Support the Project Manager (quality management Representative) during certification audits.

**QUALIFICATIONS**:
**Requirements**:

- Post-secondary degree in a science, engineering, or technical field required.
- 5+ years of experience in medical device quality management.
- Knowledge and experience working within an ISO 13485 quality management system environment in the medical device industry.
- Understanding good manufacturing practice requirements.
- Strong communication and interpersonal skills.
- Sound judgment, organizational, and analytical skills
- Excellent computer and writing skills.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to exercise effective time management skills in completion of assignments.

**Preferred**
- Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in Canada, USA, and EU.
- Working experience with sterile medical device products/accessories.
- Working experience with electro-mechanical medical devices.
- Knowledge of the IEC 62304 Medical Device - Software Life Cycle Processes.
- Completed internal or Lead Auditor training (preferably ISO 13485).
- Experience implementing/auditing to ISO 13485, ISO 14971, and medical device and /or pharmaceutical regulatory requirements.
- Understanding of clinical trial conduct and good clinical practice guidelines.

**Disclaimer
The above information on this job description and specifications has been designed to indicate the general nature and level of work performed within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required. The job description and specifications may change from time to time, as required by the company.