Senior Quality Analyst

Senior Quality Analyst

Job Location s: US-MA-North Billerica

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.

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…