CAPA Facilitator Associate

Hologic, Inc.; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. currently has two openings for a CAPA Facilitator Associate.

You will support a broad range of quality system and assurance activities, using data 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 role for an experienced professional who can work independently, exercise sound judgment, and resolve a wide range of quality‑related issues

Qualifications

• Experience in Quality Assurance or Quality Systems in regulated environments.
• Experience with CAPA processes and effectiveness checks.
• Ability to analyze data and develop KPIs and quality metrics.
• Familiarity with audit preparation and regulatory inspections.

Responsibilities

• Support quality values and system requirements across the division.
• Collaborate with team members and cross-functional teams.
• Coordinate quality activities under the QA Manager supervision.
• Lead CAPA processes including corrective and preventive actions.
• Provide guidance on root cause evaluation and CAPA effectiveness.
• Review CAPA system daily and coordinate resource needs.
• Maintain and improve the divisional CAPA toolbox and materials.
• Prepare and manage documentation from CAPA Review Board meetings.
• Serve as contact for CAPA process and support global process improvements.
• Participate in internal and external quality audits and inspections.
• Assist with data analysis and KPI development.
• Review open Quality Plans and provide updates.

Skills

Quality Assurance

Root Cause Analysis

Data Analysis

Communication

Cross‑functional Collaboration

Education

Technical Bachelor's degree

Tools

Agile PLM

QMS software

Job description

At Hologic, wecurrently 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.

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.

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.

Education

• Technical Bachelor’s degree or higher preferred.

Experience

• 2-6 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
• Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.