Senior CAPA & Investigation Specialist — QMS Remediation

Philips; Bedford (MA); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Philips is seeking a Senior CAPA & Investigation Specialist to support a high-priority QMS remediation initiative. This role focuses on reviewing, assessing, and remediating existing CAPA records to ensure documentation meets regulatory requirements and inspection readiness.

The ideal candidate has medical device industry experience, strong CAPA leadership, investigations skills, and a track record of remediation after audits or regulatory observations.

Competenze

• Bachelor's degree required.
• Medical Device industry experience required.
• Demonstrated CAPA ownership and leadership experience.
• Experience conducting quality investigations.
• Strong Root Cause Analysis experience.
• Working knowledge of ISO 13485 requirements.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820/QMSR).
• Strong technical writing and documentation skills.
• Experience supporting quality system remediation projects.
• Ability to independently review and assess large volumes of quality records and documentation.

Mansioni

• Review historical CAPA records and supporting documentation.
• Assess investigations for completeness, effectiveness, and regulatory compliance.
• Identify and remediate documentation deficiencies and compliance gaps.
• Conduct and support root cause analysis activities.
• Evaluate corrective and preventive actions for adequacy and effectiveness.
• Review and validate effectiveness checks.
• Strengthen investigation quality and documentation integrity.
• Support quality system remediation initiatives and inspection readiness efforts.
• Partner with cross-functional stakeholders to drive CAPA remediation activities to closure.

Conoscenze

CAPA Management

Technical Writing

Quality System Remediation

Regulatory Compliance

Inspection Readiness

Documentation Review and Remediation

Cross-Functional Collaboration

Formazione

Bachelor's degree

Strumenti

Greenlight Guru

Descrizione del lavoro

Philips is seeking a Senior CAPA & Investigation Specialist to support a high-priority QMS remediation initiative. This role focuses on reviewing, assessing, and remediating existing CAPA records to ensure documentation meets regulatory requirements and inspection readiness.

The ideal candidate has medical device industry experience, strong CAPA leadership, investigations skills, and a track record of remediation after audits or regulatory observations.