Overview
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.
Responsibilities
* 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.
* Participate in 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 causes analysis and implementation of corrective and preventive actions (CAPA).
* 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.
* Oversee equipment qualification and process validation activities (IQ/OQ/PQ) performed at supplier and CMO sites, ensuring documented evidence of compliance.
Experience, Qualifications & Skills
* Bachelor or Master’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., MasterControl, TrackWise, Veeva, or similar) is a plus.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Medical Equipment Manufacturing
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