CAPA Facilitator Associate

Hologic • Newark, NJ

1d

About The Position

Hologic is hiring two CAPA Facilitator Associates to support quality system and quality assurance activities across a division. This career-level role uses data, quality tools, and cross-functional collaboration to assess issues, document outcomes, support investigations, and contribute to continuous improvement. The successful candidate works independently on day-to-day responsibilities, exercises sound judgment, and resolves quality-related issues using practical methods.

The position facilitates CAPA and nonconformance processes, supports divisional Management Reviews, provides root-cause and CAPA-effectiveness guidance, and serves as a divisional contact for CAPA. It also supports internal and external audits and regulatory inspections; maintains quality documentation, procedures, training resources, and metrics; and coordinates with functional teams to improve quality processes and audit readiness.

Hologic provides comprehensive onboarding and continued training and development. The role offers a competitive salary and annual bonus. The annualized base salary range is $78,000–$122,100 and the position is bonus eligible. Final compensation depends on factors including experience, skills, knowledge, geography, education, business needs, and market demand.

Requirements

• Two to six years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
• Experience working in 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, 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, including the ability to work across organizational functions and levels.
• Good judgment in selecting methods, tools, and techniques to resolve quality issues.
• Ability to manage diverse tasks with minimal day-to-day supervision.

Nice To Haves

• Technical bachelor's degree or higher preferred.
• Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry is advantageous.
• Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.

Responsibilities

• Support and model quality values, quality system requirements, and best practices across the division.
• Collaborate with team members, stakeholders, and cross-functional teams throughout the organization.
• Coordinate assigned quality activities and support the Quality Assurance department as directed by the Quality Assurance Manager.
• Facilitate CAPA program activities, process nonconformance activities, and divisional Management Review administration.
• Provide guidance on root-cause evaluation and monitor CAPA effectiveness after closure.
• Review the CAPA system daily 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 front-room and/or back-room audit workstreams.
• Support audit and inspection preparation by communicating with functional areas and collecting relevant data.
• Collect and organize divisional Management Review materials.
• Modify, maintain, and create procedures and processes as required.
• Assist with data analysis and development of quality metrics and KPIs for various functions.
• Review open site Quality Plans (QPLs) and recommend updates.
• Support FDA inspections and other regulatory audit activities, as applicable.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Competitive salary.
• Annual bonus scheme.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level