Quality Operations Specialists

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 SummaryThe 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.ResponsibilitiesDevice History Record (DHR) ReviewPerform detailed reviews of Device History Records (DHRs) to ensure completeness, accuracy, and compliance with approved procedures and manufacturing requirementsVerify that all manufacturing, inspection, testing, labeling, and packaging activities have been completed and documented appropriatelyReview production records for compliance with specifications, acceptance criteria, and quality requirementsIdentify documentation discrepancies, missing information, and record errors requiring correction prior to releaseCoordinate with Manufacturing, Engineering, and Quality personnel to resolve DHR review findings in a timely mannerMaintain accurate review documentation and release records in accordance with established proceduresProduct Release ActivitiesPerform product disposition and release activities in accordance with established quality system proceduresVerify that all required inspections, testing, and acceptance activities have been successfully completed prior to product releaseEnsure all non-conformances, deviations, and quality events impacting product release have been appropriately addressed and documentedReview quality data and supporting documentation to support release decisionsSupport timely release of finished goods while maintaining compliance with regulatory and quality requirementsEscalate quality concerns or release risks to Quality leadership when appropriateManufacturing Quality SupportPartner with manufacturing teams to ensure production documentation meets quality requirementsSupport resolution of documentation and recordkeeping issues identified during production and review activitiesAssist with implementation of process improvements related to manufacturing documentation and product release workflowsParticipate in production meetings and provide quality input regarding documentation and release readinessQuality System ComplianceEnsure activities comply with ISO 13485, FDA Quality System Regulation, and applicable internal proceduresSupport investigations related to documentation errors, record discrepancies, and product release issuesParticipate in internal audits and inspection readiness activities related to manufacturing records and product release processesSupport CAPA, nonconformance, and change control activities as assignedMetrics and Continuous ImprovementTrack and report DHR review and product release metricsIdentify recurring documentation issues and opportunities for process improvementSupport continuous improvement initiatives to improve record accuracy, review efficiency, and overall quality system effectivenessAssist in development and implementation of best practices for manufacturing documentation and product release activitiesQualifications & SkillsAssociate degree in Quality, Engineering, Life Sciences, Manufacturing, or related field preferred. Equivalent combination of education and experience may be considered2–5 years of experience in Quality Assurance, Manufacturing Quality, Production Quality, or Quality Systems within a regulated industryExperience reviewing manufacturing records, batch records, Device History Records (DHRs), or equivalent production documentation preferredExperience working within an ISO 13485 and/or FDA-regulated medical device environment preferredFamiliarity with product release or product disposition processes preferredStrong attention to detail and documentation review skillsAbility to identify discrepancies and assess compliance with established proceduresStrong organizational and time management skillsEffective written and verbal communication skillsProficiency with Microsoft Office applications and electronic quality management systems (eQMS) and ERP/MES systemsAbility to work independently while managing multiple priorities in a fast-paced manufacturing environmentPreferred Candidate ProfileExceptional attention to detail and ability to identify discrepancies, omissions, and documentation errorsStrong recordkeeping and documentation management skills with a demonstrated ability to maintain accurate, complete, and organized recordsExperience reviewing large volumes of documentation while maintaining a high degree of accuracy and consistencyAbility to follow established procedures, work instructions, and quality requirements with minimal oversightStrong analytical and verification skills with a methodical and disciplined approach to workExperience in documentation review, document control, inventory control, production record review, bookkeeping, data entry, or other highly detail-oriented administrative functions is highly desirableDemonstrated ability to manage repetitive review activities while maintaining accuracy and complianceStrong organizational and time management skills with the ability to prioritize workload and meet release timelinesComfortable working with electronic quality systems, ERP systems, databases, and controlled documentationPowered by JazzHRxxm0qlBtES