Senior Quality Assurance Associate, Systems

Job Description Summary

STEMCELL Technologies is searching for a Senior Quality Assurance (QA) Associate to join our QA Systems team!

• 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 QMS compliance, analyze quality data (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

• 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

We offer a competitive salary and meaningful career development opportunities. The annual salary range for this position is $72,700 – $98,300, determined by experience, education, and job‑related skills. The compensation package also includes health benefits, retirement savings, and other total rewards.

As an equal‑opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. STEMCELL enforces a zero‑tolerance policy for discrimination and bases all selection decisions solely on job‑related factors.