C&R Process Excellence Lead

Philips International; Bothell, Northern (WA, KY); Hybrid; USD 134,000 - 186,000; Full time

Benefits offered by this job

PTO

401k

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a governance-focused expert to ensure C&R processes are clear, consistent, and compliant with global regulations. You will lead process ownership, risk assessment, and continuous improvement across the organization, working with a Capabilities & Strategy Leader on the framework, maps, templates, and guidance.

The role requires a strong regulatory mindset, with 5+ years in Pharma/IVD/Medical Device quality functions and experience with FDA, EU MDR, and Health Canada

Qualifications

• Bachelor's or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 5+ years of experience in Pharma, IVD, Medical Device, Quality Assurance, or Clinical Research.
• Minimum 5 years in Correction & Removal, Field Action or Post-Market Surveillance.

Responsibilities

• Own and govern C&R processes to ensure regulatory alignment.
• Identify gaps, risks, and implement practical improvements.
• Lead change requests from intake to effectiveness monitoring.
• Promote AI and digital tools to improve process efficiency and knowledge management.

Skills

Regulatory knowledge

Process governance

C&R expertise

AI tools awareness

Education

Bachelor's/Master's in Medical Sciences

Job description

Philips is seeking a governance-focused expert to ensure C&R processes are clear, consistent, and compliant with global regulations. You will lead process ownership, risk assessment, and continuous improvement across the organization, working with a Capabilities & Strategy Leader on the framework, maps, templates, and guidance.

The role requires a strong regulatory mindset, with 5+ years in Pharma/IVD/Medical Device quality functions and experience with FDA, EU MDR, and Health Canada