Quality Engineer

The Quality Operations Engineer plays a critical role in ensuring that products manufactured by external suppliers and CMOs meet applicable regulatory, quality, and business requirements. This individual serves as a key liaison between the company and its external manufacturing partners, driving quality oversight across manufacturing, incoming inspection, and product release. The position involves hands‑on review of batch records, investigation of nonconformances, support for equipment qualification (IQ/OQ/PQ), and verification of incoming materials, all in accordance with ISO 13485, FDA QSR, and other applicable standards.

• Collaborate with CMOs and suppliers to ensure quality deliverables are met throughout the product lifecycle, from material receipt to final release.
• Perform review and approval of manufacturing batch records, ensuring compliance with product specifications, Good Manufacturing Practices (GMP), and internal procedures.
• Support incoming inspection activities: review Certificates of Analysis (CoA), dimensional and visual inspection reports, and material certifications; assist in material disposition and drive resolution of discrepancies.
• Participate in nonconformance (NC) review and disposition, including root cause analysis and implementation of corrective and preventive actions (CAPA).
• Oversee or support equipment qualification and process validation activities (IQ/OQ/PQ) performed at supplier and CMO sites, ensuring documented evidence of compliance.
• Support or lead batch release activities, including review of DHRs (Device History Records) and verification of QC test results.
• Interface with Regulatory Affairs, Procurement, and Manufacturing teams to ensure timely product release and issue resolution.
• Participate in supplier audits, readiness assessments, and quality improvement initiatives.
• Ensure compliance with applicable ISO 13485, FDA 21 CFR Part 820, MDR, and internal QMS policies.
• Maintain accurate quality documentation and records in accordance with document control and record retention requirements.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of 3–5 years of experience in Quality Assurance, ideally in a medical device or pharmaceutical manufacturing environment.
• Knowledge of ISO 13485, FDA QSR, and GxP regulations.
• Experience working with CMOs and suppliers, especially in a regulated environment.
• Familiarity with batch record review, NC/CAPA processes, IQ/OQ/PQ, and risk‑based quality approaches.
• Strong analytical and problem‑solving skills.
• Excellent communication and collaboration abilities.
• Experience with quality management systems (e.g., Master Control, Track Wise, Veeva, or similar) is a plus.