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Quality & Regulatory Assurance Specialist

2 weeks ago

Delta, Canada Artron BioResearch Inc. Full time

**About Us**

Artron BioResearch Inc is a technology-based manufacturer specialized in the development and large-scale production of antibodies and antigens. Employing the best practices in developing rapid diagnostic technology has given the company invaluable hands-on expertise to provide our clients with the best-matched pairs of monoclonal antibodies and recombinant antigens in the industry. At Artron, we are committed to going above and beyond to meet the rapid diagnostic industry participants' specific challenges. Our focus on guiding our customers every step of the way allows our clients to receive the best in class customer service.

We are looking for a bright, highly organized individual to join our team At Artron, we offer a competitive salary and benefits package, dental and vision extended health insurance, a flexible and friendly working environment, year-end bonus, free holiday gifts.

**Responsibilities**:

- Process ISO 13485 and MDSAP certification and handle the regular audit and review for the corporation
- Record and organize all necessary documentation for the implementation, maintenance, and effectiveness of the quality management system
- Oversee quality management system and ensure compliance with all local, provincial, federal, and international requirements
- Maintain good documentation and record under the quality management system
- Make recommendations for improvements and implement changes in all processes.
- Provide training as required by ISO 13485 and MDSAP coaching to all staff and contractors as necessary
- Participate in the strategic planning process related to the QA department
- Liaise with external agencies and customers on matters of quality
- All other job functions assigned within the domain of QA functions by management

**Qualifications**:

- Bachelor’s degree in relevant fields
- Minimum 2 years of QA experience, preferred in ISO 13485 and MDSAP
- Strong teamwork, time management, and project management skills
- Strong communication skills and attention to detail

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

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift

**Education**:

- Bachelor's Degree (required)

**Experience**:

- quality assurance: 2 years (required)

**Language**:

- Mandarin, Chinese (preferred)

Work Location: In person