Job Description

Job Title:

Quality Assurance and Regulatory Affairs Assistant

Location

: Vancouver, BC

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 Assistant for part-time employment. You will work closely with the Quality Assurance/Regulatory Affairs team in 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, distribution, training, filing and archival of controlled documents. Ensure all records are up-to-date and comply with regulatory guidelines. Participate in the preparation for internal and external audits, review and follow-up of audit findings to ensure corrections and corrective/preventive actions are implemented. 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 supplier qualification activities. Collaborate with cross-functional teams to address quality and regulatory issues and drive continuous improvement initiatives. Ensure all complaints, adverse events, and product non-conformances are properly documented. Support with post-market surveillance activities in monitoring medical device recalls and alerts 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. 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, 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 Proficiency in Microsoft Office applications.
If you are interested in joining our team as a Quality Assurance and Regulatory Affairs Specialist, please submit your resume and cover letter to hiring@pacificsurgical.ca. Only short-listed candidates will be contacted. No phone inquiries please.

Job Type: Part-time

Pay: From $21.00 per hour

Expected hours: 20 per week

Benefits:

Casual dress On-site parking
Flexible language requirement:

French not required
Schedule:

Day shift Monday to Friday
Ability to commute/relocate:

Vancouver, BC V5X 2X7: reliably commute or plan to relocate before starting work (required)
Education:

Bachelor's Degree (required)
Work Location: In person