Senior Quality Analyst

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 Senior Quality Analyst is responsible for leading and supporting Quality Assurance activities across the product lifecycle using and applying technical knowledge, statistical methods and data-driven analysis within a regulated medical device environment. This role supports continuous improvement and development of new quality methods to support manufacturing and product development. In conducting these activities the Senior Quality Analyst applies advanced statistical techniques to assess product and process risk, support design, development and manufacturing projects and decisions, and ensure compliance with applicable regulatory and quality standards. In addition to the functions above, the Senior Quality Analyst coordinates risk management activities, and participates in broader quality system activities, including CAPA, nonconformance investigations, audits, and continuous improvement initiatives. Other activities as assigned including gauge repeatability and reproducibility, equipment and process qualification and validations, and root cause investigations (i.e., related to CAPAs, QN/Is, or other quality activities). This position requires strong analytical expertise, sound knowledge of medical device regulations, and the ability to collaborate cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Operations.

Major Duties and Responsbilites

Quality System Support

Participate in and support CAPA, nonconformance, deviation, and statistical evaluation of complaint trending and other quality investigations using data-driven root cause and statistical analysis techniques.
• Provide technical and statistical input to validation activities (process validation, test method validation, and software validation as applicable).
• Support internal, supplier, and regulatory audits by preparing documentation, analyzing data, and responding to audit findings.
• Contribute to continuous improvement initiatives by identifying process improvements based on statistical and risk-based analyses.
• Support the development and tracking of Quality and Operations KPIs (i.e., NCPs, Deviations, Inspection data, Facility and Laboratory data).
• Support Supplier Qualification maintenance and evaluation.
• Participate in Design of Experiments and test protocol development and finished reports (i.e., electrical testing related to 60601).
  

Cross-Functional Collaboration & Communication

• Partner with R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams to integrate appropriate quality documentation practices and risk management principles into product and process decisions.
• Prepare and present risk and quality data summaries to stakeholders and leadership in a clear and actionable manner.
• Mentor and provide guidance to junior quality team members on quality subjects, statistical tools and risk management best practices.
  

Compliance & Documentation

• Ensure quality activities comply with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and company quality system procedures.
• Author, review, and approve quality documentation, including reports, qualification and validation documentation, CAPAs, continuous improvement documents, SOPs, risk assessments, and statistical analyses.
• Support inspection readiness and ongoing compliance with regulatory and customer requirements.
  

Risk Management & Statistical Analysis

• Lead and support product and process risk management activities in accordance with ISO 14971, including risk assessment, Failure Mode Effect Analysis, hazard identification, analysis, evaluation, control, and residual risk assessment.
• Apply statistical tools and methodologies (e.g., Minitab, trend analysis, capability analysis, reliability analysis, hypothesis testing) to evaluate quality and compliance risks.
• Analyze quality data to identify emerging risks, adverse trends, and opportunities for risk reduction.
• Support risk-based decision making throughout design, development, manufacturing, and post-market activities.
• Maintain and update risk management files, ensuring traceability to design inputs, verification/validation, complaints, and CAPA.
• Support Operations and Manufacturing by creating Control Charts to indicate performance against operational KPIs.
  

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.
• Must be able to analyze, concentrate, and solve complex issues throughout the workday.

Minimum Education or Equivalent Experience Required/Preferred

• Bachelor of Science Degree with at least 7 years of experience or demonstrated success within Medical Device Quality Assurance functions.

Competencies Required or preferred

• Expertise in understanding and applying principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
• Advanced skills using Microsoft Word and Excel.
• Ability to independently conduct product or process quality investigations.
• Ability to interact in internal and external audits and act as a role model for the QA department.
• Detail and process oriented.
• 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

• Not anticipated. However, must be able to travel by car/air to other MBI locations and/or supplier locations as needed.

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*