Quality Engineer, Systems & Compliance

Team: IT

Location: US

Commitment: Full-time

Workplace Type: remote

Accountabilities:

• Lead qualification and validation of GxP-regulated systems, including eQMS, COTS, and TPS platforms, using risk-based methodologies aligned with GAMP 5 and FDA CSA guidance.
• Develop, execute, and maintain validation plans, reports, UAT scripts, and traceability matrices while ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11.
• Administer and continuously improve eQMS workflows, including CAPA, deviations, NCRs, change controls, and document management.
• Manage the Vendor Qualification Program and TPS audit schedule, including initial qualification, requalification, performance monitoring, and maintenance of approved vendor lists.
• Lead internal and vendor audits end-to-end: planning, execution, reporting, and CAPA follow-up through verified closure.
• Support sponsor audits and regulatory inspections by coordinating readiness, facilitating evidence collection, and tracking closure of findings.
• Apply ALCOA+ data integrity principles to system records, validation documentation, and QMS content.
Requirements:
• Bachelor’s degree in Science, Engineering, IT, or related field (advanced degree preferred).
• Active certified auditor credential (ASQ CQA, ISO Lead Auditor, or equivalent).
• 5–8 years of experience in quality assurance within clinical trials, pharmaceutical, or medical device/SaMD environments.
• Hands-on experience with GxP system validation using GAMP 5 and FDA CSA guidance, including IQ/OQ/PQ and UAT.
• Proven expertise in vendor and third-party system qualification, audit execution, and CAPA management.
• Experience administering eQMS platforms (e.g., Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl).
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, ISO 13485, ICH E6(R3), and risk-based compliance methodologies.
• Strong analytical, communication, and cross-functional collaboration skills.
• Ability to work independently in a remote-first, regulated environment while maintaining inspection readiness.
• Preferred: Experience applying Lean, Six Sigma, or other process improvement methodologies to QMS and validation workflows.
Benefits:
• Competitive salary range: $95,000–$105,000 USD.
• Remote-first work environment with flexible work practices.
• Generous paid time off: 20 vacation days, 10 personal days, and 10 public holidays.
• 401(k) matching up to 3% of annual salary.
• Comprehensive health, dental, and vision coverage, fully employer-sponsored short-term and long-term disability, and life insurance.
• Pre-tax benefits including healthcare and dependent care flexible spending accounts.
• Learning and development opportunities, including mentorship and support for professional certifications.