Quality Systems Specialist

Job Overview

Job Requirements

Qualifications

• Bachelor’s degree in Engineering, Quality Assurance or a related field preferred; equivalent relevant experience will be considered.
• 2–3 years of document-control experience, preferably in electronics manufacturing or a regulated industry, with experience supporting audits and maintaining compliance documentation.
• Hands-on experience administering, supporting or acting as a superuser for an eQMS, including system configuration, testing, troubleshooting and legacy-data migration.
• Strong working knowledge of ISO 9001, ISO 13485, FDA regulations and 21 CFR Part 11, with the ability to support audit preparation and regulatory compliance.
• Strong analytical, organizational and communication skills, with the ability to interpret technical drawings and specifications, solve problems and collaborate effectively across functions in a fast-paced environment.

We thank all candidates for their time. Please be advised, once the profile is reviewed by our talent team, only those selected to proceed will be contacted to discuss next steps. All applicants must be legally eligible to work in Canada at the time of hire.

Our client has engaged us to support this recruitment initiative and has confirmed that the role is currently active 

We use AI tools to support certain administrative and operational aspects of our recruitment process. AI is not used to automatically screen, rank, select, or reject candidates. Those decisions are made by qualified human reviewers.

IKON Complete Inc. is committed to providing accessibility to qualified candidates with disabilities. Requests for accommodation can be made at any time at ikoncomplete.com/accessibility-policy-aoda

What We Offer

Quality Systems Specialist

Location: Richmond, BC
Salary: $60,000 – $65,000 per year
Status: On-Site | Full-Time Permanent

We are seeking a Quality Systems Specialist to join our client, a leading manufacturer in the electronics space located in Richmond, BC. The successful candidate will contribute to and support the transfer of product designs from development into manufacturing, as well as the maintenance and continuous improvement of production processes.

Responsibilities

• Manage the full lifecycle of QMS documentation, including SOPs, work instructions, quality manuals, technical drawings, specifications and controlled records.
• Administer and support the eQMS, ensuring compliance with 21 CFR Part 11, Good Documentation Practices, ISO 9001, ISO 13485 and applicable regulatory requirements.
• Control document revisions, approvals, distribution and change requests, while conducting routine audits and driving documentation and workflow improvements.
• Support audit readiness and regulatory compliance by maintaining QMS, regulatory, engineering, NDA and quality records, and providing documentation for internal, customer and regulatory audits.
• Oversee the corporate training program, including eQMS training, employee training on document-control processes, and accurate maintenance of training records.