Company | Meridian Bioscience, Inc. | Department | Quality & Regulatory Affairs | # of Openings | 1 |
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.
Provide quality expertise and support to ensure the quality of design, sourcing and manufacturing of products meets or exceeds all internal and external requirements and standards.
Proactively participate in product development projects to support compliant processes and documentation in new product development and for design changes.
Develop, establish, and maintain well-established quality processes, methodologies, documentation systems and practices to meet customer and regulatory requirements.
Tasks/Duties/Responsibilities:
Other duties as assigned:
Minimum Education or Equivalent Experience Required/Preferred
* Bachelor's Degree required, preferably in Engineering, a medical technology (Clinical Chemistry, Medical Technology, etc.), or a relevant Science (Biology, Chemistry, Physics, etc.)
* Advanced degree preferred but not required.
* At least 7 years of experience in OEM medical device manufacturing of FDA approved or 510k cleared product.
Competencies Required or preferred
* Preferred direct experience with ISO 13485 auditing, CAPA processes, and creating procedures and creating/improving Quality Management Systems.
* Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
* Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485
* Ability to write, review, and execute deviations, nonconformance reports, CAPAs, and complaints.
* Previous experience with electronic document management systems preferred
* Ability to read, understand and follow all company SOPs and guidelines.
* Utilize critical thinking skills to problem solve and troubleshoot.
* Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
* Good organizational skills and strong attention to detail.
* Must be able to perform job requirements independently with minimal supervision.
* Adjusts easily and readily to a fast-paced work environment with changing priorities
Required Travel %:
* Potential for infrequent travel, less than 20%, to Corporate Headquarters, training locations, or vendor facilities.
*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. (USA Only)*