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 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.
Responsible for leading projects supporting remediation and implementation of the quality design and risk management processes. Support the remediation and implementation of the post-market risk assessment process. Review and modify policy and operating procedures and provide effective solutions for success. Active involvement with the remediation of the Quality System Management.
Train employees on Risk management and Design control
Review design history files for exiting LC products
Interpret and implement US law, EU Directives and/or local requirements as it pertains to Meridian Billerica and the medical industry in general.
Update and implement changes to standard operating procedures (SOP)
Support the update or creation of risk files and/or design history files.
Support the remediation and implementation of the Quality Design Quality and Risk Management processes.
Support the remediation and implementation of the post-market risk assessment process.
Knowledge, Skills and Abilities:
In-depth experience with Design Control systems for medical devices, and Quality Management Systems
Must be familiar with both FDA (CFR 820) and ISO 13485, ISO 14971 standards; IVD experience a plus.
Ability to provide training to ISO 14971 and FDA Design control concepts
Knowledgeable in cGMP, experience with Manufacturing Projects
Excellent communication and presentation skills
Education and Experience:
BS in Engineering or Life Sciences
At least 10 years of experience in manufacturing, laboratory or quality position supporting FDA regulated products
Experience working within the Medical Device and/or Pharmaceutical Industry
Experience with FDA 483 and warning letter remediation
Experience leading projects and influencing cross-functional leaders without positional authority.
Remote work is possible depending on location.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Meridian Bioscience, Inc