{"id":3649089,"url":"https://alion.io/job/meridian-bioscience-associate-production-quality-engineer","title":"Associate Production Quality Engineer","company":{"id":2303760,"name":"Meridian Bioscience","domain":"meridianbioscience.com","url":"https://alion.io/company/meridianbioscience","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Billerica, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85000,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-02T23:41:15Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T04:52:22Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About Meridian\nMeridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.\nJob Summary\nThe Associate Production Quality Engineer supports quality assurance activities within manufacturing operations and supplier quality management processes. Working under the guidance of the Senior Quality Assurance Engineer, this role helps ensure that products are manufactured and released in compliance with applicable regulatory requirements, quality standards, and company procedures. The Associate Production Quality Engineer contributes to production quality oversight, supplier performance monitoring, nonconformance investigations, and continuous improvement initiatives to support operational excellence and product quality.\nKey Duties\nProduction Quality Support\nSupport daily quality activities related to manufacturing operations and production processes.\nReview production records and quality documentation for completeness, accuracy, and compliance with established procedures.\nParticipate in manufacturing process reviews, product inspections, and production readiness activities.\nAssist with the evaluation, investigation, and disposition of nonconforming materials and products.\nMonitor quality-related production metrics and support implementation of corrective actions when required.\nCollaborate with Production, Engineering, and Operations teams to address quality issues and improve manufacturing performance.\nNonconformance and CAPA Activities\nSupport investigations of deviations, nonconformances, and production quality events.\nParticipate in root cause analysis using quality problem-solving methodologies such as 5-Why, Fishbone Analysis, and Risk Assessments.\nAssist in the development, implementation, and monitoring of Corrective and Preventive Actions (CAPAs).\nVerify completion and effectiveness of corrective actions within established timelines.\nSupplier Quality Support\nCollaborate wiith Supplier Quality Engineer to support resolution of supplier-related quality issues impacting manufacturing operations. \nEscalate supplier-related nonconformances to Supplier Quality Engineer for investigation and resolution. \nAssist in the review of supplier documentation, quality records, and corrective action responses.\nCollaborate with Supply Chain and Supplier Quality personnel to ensure timely resolution of supplier quality concerns\nQuality Systems and Compliance\nMaintain compliance with company quality system requirements and applicable regulatory standards.\nAssist in the creation, revision, and maintenance of quality procedures, work instructions, and records.\nSupport internal audits, external audits, customer audits, and regulatory inspections.\nEnsure quality documentation is completed accurately and maintained according to record retention requirements.\nContinuous Improvement\nParticipate in continuous improvement projects focused on enhancing product quality, process efficiency, and compliance.\nAnalyze quality data and prepare routine reports and trending analyses.\nSupport implementation of risk management and process improvement initiatives.\nContribute to a culture of quality, compliance, and operational excellence.\nQualifications\nBachelor’ Degree in Engineering, Manufacturing Enginering, or related technical discipline\n0 to 3 years of experience in Productio Quality, Quality Engineering, Manufacturing Quality or related function\nExperience in regulated industry such as Medical device or other related field, preferred\nBasic knowledge of Quality Management Systems (QMS), including ISO 13485, ISO 9001, FDA 21 CFR Part 820, or equivalent regulations. \nUnderstanding of manufacturing processes and quality engineering principles. \nFamiliarity with nonconformance management, CAPA processes, and root cause analysis techniques. \nKnowledge of Good Documentation Practices (GDP). \nProficiency in Microsoft Office applications. \nStrong analytical, organizational, and communication skills. \nAbility to work effectively in a cross-functional team environment.\nTravel: 5% \nCompensation Range: 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