Quality Operations Specialists

Position Summary

• Perform detailed reviews of Device History Records (DHRs) to ensure completeness, accuracy, and compliance with approved procedures and manufacturing requirements.
• Verify that all manufacturing, inspection, testing, labeling, and packaging activities have been completed and documented appropriately.
• Review production records for compliance with specifications, acceptance criteria, and quality requirements.
• Identify documentation discrepancies, missing information, and record errors requiring correction prior to release.
• Coordinate with Manufacturing, Engineering, and Quality personnel to resolve DHR review findings in a timely manner.
• Maintain accurate review documentation and release records in accordance with established procedures.

• Perform product disposition and release activities in accordance with established quality system procedures.
• Verify that all required inspections, testing, and acceptance activities have been successfully completed prior to product release.
• Ensure all non-conformances, deviations, and quality events impacting product release have been appropriately addressed and documented.
• Review quality data and supporting documentation to support release decisions.
• Support timely release of finished goods while maintaining compliance with regulatory and quality requirements.
• Escalate quality concerns or release risks to Quality leadership when appropriate.

• Partner with manufacturing teams to ensure production documentation meets quality requirements.
• Support resolution of documentation and recordkeeping issues identified during production and review activities.
• Assist with implementation of process improvements related to manufacturing documentation and product release workflows.
• Participate in production meetings and provide quality input regarding documentation and release readiness.

• Ensure activities comply with ISO 13485, FDA Quality System Regulation, and applicable internal procedures.
• Support investigations related to documentation errors, record discrepancies, and product release issues.
• Participate in internal audits and inspection readiness activities related to manufacturing records and product release processes.
• Support CAPA, nonconformance, and change control activities as assigned.

• Track and report DHR review and product release metrics.
• Identify recurring documentation issues and opportunities for process improvement.
• Support continuous improvement initiatives to improve record accuracy, review efficiency, and overall quality system effectiveness.
• Assist in development and implementation of best practices for manufacturing documentation and product release activities.

• Associate degree in Quality, Engineering, Life Sciences, Manufacturing, or related field preferred. Equivalent combination of education and experience may be considered.
• 2–5 years of experience in Quality Assurance, Manufacturing Quality, Production Quality, or Quality Systems within a regulated industry.
• Experience reviewing manufacturing records, batch records, Device History Records (DHRs), or equivalent production documentation preferred.
• Experience working within an ISO 13485 and/or FDA-regulated medical device environment preferred.
• Familiarity with product release or product disposition processes preferred.
• Strong attention to detail and documentation review skills.
• Ability to identify discrepancies and assess compliance with established procedures.
• Strong organizational and time management skills.
• Effective written and verbal communication skills.
• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS) and ERP/MES systems.
• Ability to work independently while managing multiple priorities in a fast-paced manufacturing environment.

Preferred Candidate Profile

• Exceptional attention to detail and ability to identify discrepancies, omissions, and documentation errors.
• Strong recordkeeping and documentation management skills with a demonstrated ability to maintain accurate, complete, and organized records.
• Experience reviewing large volumes of documentation while maintaining a high degree of accuracy and consistency.
• Ability to follow established procedures, work instructions, and quality requirements with minimal oversight.
• Strong analytical and verification skills with a methodical and disciplined approach to work.
• Experience in documentation review, document control, inventory control, production record review, bookkeeping, data entry, or other highly detail-oriented administrative functions is highly desirable.
• Demonstrated ability to manage repetitive review activities while maintaining accuracy and compliance.
• Strong organizational and time management skills with the ability to prioritize workload and meet release timelines.
• Comfortable working with electronic quality systems, ERP systems, databases, and controlled documentation.

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