Quality Engineer – Systems, Compliance
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Job Description
Quality Engineer responsible for validation and compliance of GxP-regulated systems in clinical trials. Collaborating across teams to ensure inspection readiness and quality assurance.
Responsibilities:
- Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS.
- Develop, execute, and maintain system validation plans, validation reports, UAT scripts, and periodic review records.
- Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management.
- Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule.
- Lead vendor qualification and audit activities end-to-end.
- Apply ALCOA+ data integrity principles across all system records.
- Manage system change controls, post-change impact assessments, and revalidation activities.
- Identify and escalate GxP system compliance risks; lead root cause analysis and drive CAPA for system-related quality events.
- Collaborate with IT and DevOps/QC on software release validation, infrastructure qualification, and integration testing in regulated environments.
- Plan, execute, report, and manage follow-up on the internal audit program per established schedule.
- Own and maintain the vendor and TPS audit schedule; lead vendor audits, remote desktop reviews, and surveillance assessments.
Requirements:
- Bachelor's Degree in Science, Engineering, Information Technology, or equivalent field.
- Active certified auditor credential (ASQ CQA, ISO Lead Auditor, or equivalent) required at hire.
- Minimum 5-8 years of experience in quality assurance within a regulated clinical trials, pharmaceutical, or medical device/SaMD environment.
- Demonstrated hands-on experience with GxP system validation using GAMP 5 (2nd ed., 2022) and/or FDA Computer Software Assurance (CSA) guidance.
- Direct experience qualifying vendors and third-party systems.
- Experience administering eQMS platforms (Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl, or equivalent).
- Familiarity with TGA, MHRA, EMA, or other international regulatory authority inspection programs.
- Experience supporting FDA QMSR or ISO 13485 third-party certification audits.
- Experience with eTMF system qualification and clinical trial data management systems.
- Experience planning and executing internal audit programs.
Benefits:
- Remote Work Practices: Cogstate is a virtual first company.
- Generous Paid Time-off: 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
- 401(k) Matching: Cogstate matches up to3% of your yearly salary in the 401k program.
- Competitive Salary: We offer competitive base salaries.
- Health, Dental & Vision Coverage: Comprehensive health & dental insurance options with competitive company contributions.
- Short-Term & Long Term Disability Life Insurance: 100% employer sponsored.
- Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts.
- Learning & Development Opportunities: Robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications.
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