Quality Operations Specialist

Job Description

Job Description

COMPANY OVERVIEW:
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. Position Summary The Quality Operations Specialist is responsible for supporting manufacturing quality operations through comprehensive review of Device History Records (DHRs), product release activities, and production quality documentation. This role ensures that Merrimack Manufacturing products meet established quality requirements, regulatory standards, and internal procedures prior to release for distribution.

The Quality Operations Specialist serves as a key quality representative within manufacturing operations and works closely with Production, Engineering, Supply Chain, and Quality teams to ensure timely review of production records, resolution of documentation issues, and compliant product disposition decisions. This position plays a critical role in maintaining compliance with ISO 13485, applicable regulatory requirements, and company quality standards.

Responsibilities

Device History Record (DHR) Review

• 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.

Product Release Activities

• 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.

Manufacturing Quality Support

• 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.

Quality System Compliance

• 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.

Metrics and Continuous Improvement

• 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.

Qualifications & Skills

• 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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