Senior Quality Assurance Associate, Systems

STEMCELL Technologies•Burnaby, BC

2d•CA$72,700 - CA$98,300•Onsite

About The Position

STEMCELL Technologies is searching for a Senior Quality Assurance (QA) Associate to join our QA Systems team! As a Senior QA Associate, you will contribute to upholding quality standards and regulatory compliance by performing key quality activities, maintaining quality documentation, and recommending continuous improvement initiatives. You will apply independent judgment to evaluate complex quality issues and implement effective solutions using current industry practices and methodologies. Through your expertise, you will help ensure that all products meet specified quality requirements and regulatory standards, contributing significantly to STEMCELL’s commitment to quality and compliance.

Requirements

Bachelor’s Degree in Life Sciences (e.g., Chemistry, Biology) or related field with 2-6 years of relevant QA experience
Knowledge of QMS, including nonconformance, CAPA, SCAR, change control, and document control
Solid understanding of regulatory requirements and industry standards, including ISO 9001, ISO 13485, CE medical/IVD device directives, and cGMP, with the ability to interpret and apply technical documents, procedures, and regulations
Demonstrated ability to coordinate QA responsibilities, maintain accurate quality and regulatory documentation, manage multiple priorities in a fast-paced environment, and apply strong organizational, project, and time management skills
Excellent communication, technical report writing, presentation, interpersonal, and cross-functional collaboration skills, with a self-motivated, independent work ethic and a willingness to learn and take on new responsibilities

Responsibilities

Perform key quality activities, focusing on nonconformance and corrective and preventive actions (CAPA) systems while supporting supplier corrective action requests (SCAR), change control, audit, and document management to maintain quality standards and ensure regulatory compliance
Conduct and facilitate investigations using industry standard methods for root cause determinations and identification of meaningful corrective and preventative actions
Conduct internal and external audits to assess compliance with applicable standards, regulations, directives, and organizational policies
Partner with cross-functional teams to ensure Quality Management System (QMS) compliance, analyze quality data (e.g., inspections, testing, audits, CAPA metrics, and quality key performance indicators), and recommend process improvements
Maintain accurate, complete, and compliant quality documentation, including policies, procedures, records, and quality system activities in accordance with regulatory requirements