Manager, Quality

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.

The Manager, Quality will implement and maintain the quality program and associated procedures to ensure overall compliance with the FDA Quality Standard Regulations (21 CFR Part 820), ISO 13485  and other local, state, and international regulations and laws, associated with maintaining a marketed medical device.

Tasks/Duties/Responsibilities:

• Ensure compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO ,CE,RoHS).
• Coordinate/perform complaint investigations and audits including supplier
• Track CAPA to ensure appropriate verification, implementation and follow-up on corrective actions.
• Work with R&D, Manufacturing and Product Support to improve product quality to meet customer requirements.
• Lead the management of and response to site inspections conducted by federal and state authorities (e.g. FDA inspections, MA.).
• Provide direction to manufacturing personnel, product hold coordinators and Material Review Board (MRB) to ensure compliance with the Company’s Quality System.
• Develop and maintain QA standard operating procedures (SOP) and review SOPs generated by other departments.
• Review and approve as needed manufacturing/test procedures (e.g. batch records and Device History Records) for products and raw materials for release into inventory and shipping.
• Review and approve validation protocols for equipment and software testing.
• Oversee any relevant instrument compliance activities such as Safety, EMC, Altitude and ISTA Packaging testing.
• Provide Quality engineering and process support to manufacturing with direct interaction with the manufacturing processes, personnel and procedures.
• Will serve as the subject mater expert for quality requirements related to new product development and product/process changes. Will review, provide guidance, and support product development and proposed product and processes changes, ensuring that the necessary quality standards are met.
• Conduct internal audits of the quality system and conduct external audits of critical suppliers as defined by QA program. Oversee the develop and maintianance of the document control process.
• Coordinate and present at management review meetings information regarding the functioning of and impact of the quality system.
• Develop and monitor regulatory/quality training for staff.
• Maintain knowledge of new developments in regulatory and quality standards that would have an impact on the operations and business of Meridain Bioscience.

Other Duties/Physical Requirements:

• Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
• As a manufacturer of invitro diagnostics there exists the possibility of exposure to blood.
• 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 or laboratory areas.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Must be able to analyze, concentrate, and solve complex issues throughout the workday.

Minimum Education or Equivalent Experience Required/Preferred:

• BS degree in Engineering, Quality, Biology, Microbiology, or Chemistry .
• Minimal 10 years of QA experience with a medical device manufacturer; 5+ years in a leadership role.
• Experience in all facets of the Quality Management System a plus

Competencies Required or preferred:

• Working knowledge of process improvement techniques.
• Strong communication (written and verbal) and computer skills.
• Must be able to work with minimal supervision from senior management.
• Ability to effectively manage multiple and changing priorities.
• Excellent ability to collaborate to achieve objectives and problem-solve.
• Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.
• Understanding of Computer validation (FDA 21 CFR Part 11) and Equipment Validation requirements.
• Experience in handling and coordinating responses to FDA and ISO inspections.
• Continued education to keep up to date with changing global requirements.

Required Travel %:

• 0-10% travel

*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)*