Manager, Quality - Billerica - Meridian Bioscience

    Meridian Bioscience
    Meridian Bioscience Billerica

    1 day ago

    $80,000 - $135,000 (USD) per year *
    Description

    About Meridian Bioscience

    Meridian 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 redefining the possibilities of life from discovery to diagnosis. Our innovative culture will allow interested candidates to discover and create through collaboration cutting edge solutions to tough problems.

    Job Summary

    The Manager Quality will implement and maintain the quality program associated procedures ensuring overall compliance with FDA quality standard regulations 21 CFR Part 820 ISO 13485 local state international regulations laws maintaining marketed medical device.

    • Ensure compliance organization's policies applicable national international quality standards regulations eg iso CE RoHS
    • P Coordinate/perform complaint investigations audits supplier track CAPA appropriate verification implementation follow-up corrective actions.
    • # Work R D Manufacturing Product Support improve product quality meet customer requirements # Lead management response site inspections conducted federal authorities e.g FDA MA Provide direction manufacturing personnel product hold coordinators Material Review Board MRB ensure compliance Company's Quality System Develop QA standard operating procedures SOPs review SOPs generated departments Review approve as needed manufacturing test procedures batch records Device History Records release inventory shipping validation protocols equipment software testing Oversee relevant instrument activities Safety EMC Altitude ISTA Packaging testing Provide Quality engineering process support manufacturing direct interaction processes procedures Will serve subject mater expert quality requirements new product development proposed changes necessary standards met Conduct internal audits system external critical suppliers defined program overseen develop document control process Coordinate present information at management meetings functioning impact systems regulatory training staff Maintain knowledge developments would have impact operations business Meridian Bioscience Other DutiesPhysical Requirements Li Must able National Institute Occupational Safety Health NIOSH Standards As manufacturer invitro diagnostics exists possibility exposure blood Must wear personal protective equipment gloves safety glasses face shields lab coat etc Adhere applicable bio-safety practices manufactured floor laboratory areas Ability work PC including repetitive use keyboard mouse long periods course workday Analyze concentrate solve complex issues throughout workday H Qualifications Minimum Education Equivalent Experience Required Preferred Degree Engineering Biology Microbiology Chemistry minimal years experience QA leader role leadership position in all facets Quality Management System plus Competencies Required or preferred Working knowledge improvement techniques Strong communication written verbal computer skills Able work minimal supervision senior manage multiple changing priorities Excellent ability collaborate achieve objectives problem-solve strong knowledge ISO standards FDA guidance ###
    * This salary range is an estimation made by beBee
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