Senior CAPA Manager

$116,000 - $200,000/Yr

Philips - Cambridge, MA

Full-time - Senior

Onsite - Cambridge, MA

Repair and Maintenance

About the position

The Senior CAPA Manager plays a crucial role in the Sleep & Respiratory Care Patient Safety and Quality organization, leading a high-performing team focused on managing Corrective and Preventative Actions (CAPA) from issue identification to resolution. This position involves project management, cross-functional collaboration, and ensuring compliance with regulatory standards while driving quality improvements.

Responsibilities

• Manage and lead cross-functional teams of CAPA Facilitators in implementing root cause analysis techniques.
• Project manage all aspects of CAPA activities, including resource commitment and scheduling team meetings.
• Ensure the quality of CAPA record content and represent CAPA during audits and CAPA Review Board meetings.
• Facilitate CAPA investigations from issue identification through solution implementation and effectiveness monitoring.
• Analyze quality monitoring data and apply statistical techniques to identify causes of non-conformances.
• Collaborate with management to ensure CAPA action plans are supported and resources are available.

Requirements

• Minimum of 8 years' experience in CAPA within FDA regulated medical device environments.
• At least 3 years of functional management experience in developing and mentoring quality teams.
• Strong analytical skills to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated knowledge of tools and techniques for thorough root cause analysis and investigations.
• Understanding of global regulations and standards such as 21 CFR Parts 803, 806, 820, ISO 13485, ISO 9001, and ISO 14971.
• Strong CAPA Project Management skills, including data analysis and statistical techniques.
• Ability to effectively interact with and influence employees and managers at all levels.
• Bachelor's Degree in Engineering, Quality, or related disciplines; Master's Degree preferred; ASQ certifications preferred.

Nice-to-haves

• ASQ Certified Quality Engineer (CQE) certification
• ASQ Certified Quality Auditor (CQA) certification
• DfSS Green Belt/Black Belt certification

Benefits

• Generous PTO
• 401k with up to 7% match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement
• Annual incentive bonus
• Sales commission or long-term incentives