CAPA Facilitator Associate

At Hologic, we currently have two opening for a CAPA Facilitator Associate. As a CAPA Facilitator Associate, you will support a broa d range of quality system and quality assurance activities. You will use data, quality tools, and cross-functional collaboration to assess issues, document outcomes, support investigations, and contribute to continuous improvement across the division.

This is a fully qualified, career-level position suited to an experienced professional who can work independently on day-to-day responsibilities, exercise sound judgment, and resolve a wide range of quality-related issues in a creative and practical way.

• Support and model quality values, quality system requirements, and best practices across the division.
• Collaborate effectively with junior team members, peers, senior stakeholders, and cross-functional teams across the organization.
• Coordinate assigned quality activities and provide support to the Quality Assurance department as directed by the Quality Assurance Manager.
• Facilitate key quality assurance processes including:
• Corrective and Preventive Action, CAPA, program activities
• Process nonconformance activities
• Divisional Management Review administration
• Provide guidance and expertise on root cause evaluation and monitor CAPA effectiveness after closure.
• Perform daily reviews of the CAPA system to identify escalations and coordinate with departments to ensure appropriate resourcing.
• Own, maintain, and improve the divisional CAPA toolbox, including training materials, reference documents, and supporting resources.
• Prepare and manage documentation and follow-up actions from site CAPA Review Board meetings.
• Serve as a divisional point of contact for the CAPA process and provide input into global process improvements and training content.
• Participate in internal and external quality audits, including supporting front-room and/or back-room audit work streams.
• Support audit and inspection preparation by communicating with functional areas and collecting relevant data to improve audit efficiency.
• Administer the collection and organization of divisional Management Review materials.
• Modify, maintain, and create procedures and processes as required.
• Assist with data analysis and the development of key performance indicators, KPIs, for various functions.
• Review open site Quality Plans, QPLs, and provide recommendations for updates.
• Support FDA inspections and other regulatory audit activities, as applicable.

• Experience working within Quality Assurance, Quality Systems, or a related regulated environment.
• Working knowledge of Quality Management Systems, QMS.
• Experience supporting CAPA processes, root cause analysis, effectiveness checks, and quality investigations.
• Understanding of audit preparation and support activities, including internal audits, external audits, and/or regulatory inspections.
• Ability to analyze data and support the development of quality metrics and KPIs.
• Experience creating, maintaining, or improving procedures, processes, training materials, or quality documentation.
• Strong communication and collaboration skills, with the ability to work across multiple functions and levels of the organization.
• Good judgment in selecting appropriate methods, tools, and techniques to resolve quality issues.
• Ability to manage diverse tasks with minimal day-to-day supervision.
• Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.

• Technical Bachelor’s degree or higher preferred.

• 2-6 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
• Experience…