Job DescriptionWe currently have
two opening for a CAPA Facilitator Associate. As a
CAPA Facilitator Associate, you will support a broad 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.
Key Responsibilities
- 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 workstreams.
- 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.
Skills and Experience
The successful candidate will ideally bring:
- 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.
What You'll Bring
- A proactive and solutions-focused approach to quality assurance.
- Strong attention to detail and documentation discipline.
- Confidence working with data and quality systems.
- The ability to influence, guide, and support others on quality system requirements.
- A commitment to continuous improvement and operational excellence.
- Professional curiosity and the ability to identify opportunities to improve quality processes.
The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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