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 ensuring materials, processes, and products meet the required specifications, which involves, but is not limited to, inspections, metrology testing, documentation, and labeling reviews. Product acceptance or rejection. Responsible for maintaining equipment calibration.

Tasks/Duties/Responsibilities:

• Perform incoming inspection on materials and product received from suppliers, contract manufacturers, or other external sources
• Perform in-process inspection of materials and products during the manufacturing process
• Perform final inspection of subassemblies, and finished goods
• Inform management of any Out of Spec (OOS), Out of Tolerance (OOT) or product / process nonconformances
• Perform manufacturing process audits
• Perform Internal Quality Audits
• Perform Quality Control (QC) testing
• Initiate Nonconformance Reports as required
• Monitor equipment calibration status, schedule and coordinate equipment calibration w/ external service providers
• Ensure that Quality records documenting QC activities are compliant with applicable standards and Procedures
• Comply with Good Manufacturing Practices (GMP) according to established procedures
• Perform other duties as assigned

Other Duties/Physical Requirements:

• Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

Minimum Education or Equivalent Experience Required/Preferred:

• 2-4 years of experience in support or 0-2 years of experience in professional role in medical device manufacturing, laboratory testing or quality control/assurance required.
• A two year degree in a life science is required (Med Tech preferred); Bachelor’s degree in a life science (Biology, Microbiology, etc.) is preferred.

Competencies Required or preferred:

• Working knowledge of FDA medical device regulations, ISO Standards (e.g., ISO 13485), and statistical sampling methods (e.g., ANSI/ASQ Z1.4 and ANSI/ASQ Z1.9)
• Ability to read, understand and follow all company procedures, policies and guidelines.
• Experience using calipers, micrometers, gauges, electronic meters (e.g., multimeter)
• Experience utilizing blueprints and/or drawings as part of the inspection process
• Good organizational skills and strong attention to detail; able to complete required tasks and documentation with minimal errors
• Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
• Must be able to perform job requirements independently with moderate supervision.
• Able to use Microsoft Office (Microsoft Outlook, Word, and Excel); Powerpoint experience is a plus
• Adjusts easily and readily to a fast-paced work environment with changing priorities
• Adaptability - Maintains positive attitude in a changing work environment
• Communication - Effectively communicates with all levels of quality, production, and other functions. Escalates issues through the appropriate channels
• Supports department compliance and productivity goals.
• Previous experience with electronic quality management systems preferred

Required Travel %:

• No travel is expected

*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)*