CAPA & Quality Systems Associate

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

Job summary

Hologic, Inc. is seeking a CAPA Facilitator Associate to 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 role is suited for an experienced professional who can work independently on day-to-day responsibilities and resolve a wide range of quality-related issues in a practical

Qualifications

• Minimum 2–6 years of experience in medical device, IVD, or pharmaceutical quality assurance.
• Experience with CAPA processes, root cause analysis, effectiveness checks, and investigations.
• Understanding of audit preparation and support activities including internal/external/regulatory inspections.

Responsibilities

• Support and model quality values and system requirements across the division.
• Collaborate with junior staff, peers, senior stakeholders and cross-functional teams.
• Coordinate quality activities and provide support to Quality Assurance as directed by QA Manager.
• Facilitate CAPA program activities including corrective actions and process improvements.
• Provide guidance on root cause evaluation and monitor CAPA effectiveness after closure.
• Perform daily CAPA system reviews and coordinate with departments for resourcing.
• Maintain and improve the divisional CAPA toolbox and training materials.
• Prepare and manage documentation from site CAPA Review Board meetings.
• Serve as a divisional contact for CAPA and contribute to global process improvements.
• Support internal and external audits and assist with audit preparation.

Skills

Quality Assurance

CAPA

Root Cause Analysis

Data Analysis

KPIs

Training Materials

Education

Technical Bachelor's

Job description

Hologic, Inc. is seeking a CAPA Facilitator Associate to 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 role is suited for an experienced professional who can work independently on day-to-day responsibilities and resolve a wide range of quality-related issues in a practical