Quality & Compliance Coach - Senior Manager

Job Title: Quality & Compliance Coach - Senior Manager

 Intake Call Notes:

• Overview Philips is seeking a senior-level Quality & Compliance Coach to support the Ultrasound manufacturing site in Reedsville, PA. This is a highly strategic, senior manager level contingent role focused on strengthening quality culture, driving QMS execution, closing Warning Letter gaps, and ensuring continuous audit readiness.

  
  

  • Location: Reedsville, PA (onsite)

  • Will be required to be onsite a minumum for 4 days a week but most of the time will be 5.

  • Client: Philips Ultrasound Manufacturing

  • Level: Senior Manager

  
  
  

  • Business Need: Address Warning Letter gaps and improve audit/inspection readiness across the site.

    
    

    Key Hiring Priorities

    
    

    • Strong coaching mentality is critical.

      
      

      • Must be able to train, mentor, and develop teams.

      • Able to explain the "why behind the what" and build organizational competency around quality practices.

      • Experience coaching leaders, SMEs, and direct reports preferred.

      
      

    • Extensive Medical Device Quality experience required.

      
      

      • Majority of career should be in FDA-regulated medical device manufacturing.

      • Deep expertise in quality systems, compliance, and regulatory frameworks.

      
      

    • Audit & Inspection Readiness Expert.

      
      

      • Significant experience preparing sites for FDA and Notified Body inspections.

      • Strong understanding of both Front Room and Back Room audit processes.

      • Candidate representative experience during audits/inspections is highly desirable.

      
      

    • Quality Leadership Background.

      
      

      • Prior Management Representative experience or equivalent quality leadership role.

      • Proven ability to drive QMS effectiveness, management reviews, and inspection readiness activities.

      
      
    
    

    Required Experience

    
    

    • Bachelor's degree in Engineering, Life Sciences, or related technical field.

    • 15+ years of experience in FDA-regulated medical device manufacturing.

    • Someone who has been in a senior level quality manager that has done review and coaching will be a good candidate.

    • Extensive experience with:

      
      

      • QMS compliance

      • Inspection readiness

      • Internal audits

      • CAPA

      • Continuous/process improvement

      • Regulatory inspections

      
      
    
    

    Technical Expertise

    
    

    • QMSR

    • FDA 21 CFR Part 820

    • ISO 13485

    • EU MDR

    • ISO 14971 / Risk Management

    • PFMEA

    • Root Cause Analysis

    • CAPA

    • Nonconformances

    • Quality notification processes

    
    

    Primary Responsibilities

    
    

    • Serve as the onsite Quality & Compliance Coach.

    • Lead Quality Walks to reinforce quality culture and process discipline.

    • Coach site leaders and SMEs on translating regulatory requirements into sustainable daily practices.

    • Drive inspection readiness activities and audit preparation.

    • Partner across Manufacturing, Quality, Regulatory, Engineering, and Operations.

    • Use quality data and observations to identify risks and improve first-time-right performance.

    • Build accountability, ownership, and compliance-focused behaviors across the site.

    
    

    Ideal Candidate Profile

    
    

    ✅ 15+ years in medical device quality/compliance✅ Former Management Representative or similar quality leader✅ Extensive FDA and Notified Body inspection experience✅ Strong Front Room/Back Room audit expertise✅ Proven coach, mentor, and team developer✅ Comfortable influencing leaders and cross-functional teams✅ Skilled in driving quality culture transformation and audit readiness 

    
    

    Coaching mentality- they need to be willing to train, how do you build the base level of competency the why behind the what- past experience as coaching, leading direct line reports- someone with those types of capabilities also a manufacturing quality background with medical device experience.

    
    

    Sr Manager- at least 15 years' experience most likely.

    
    

    Have to do this really well- audit experience, front room or back room- prepping the site to be ready for those audits- candidate rep experience is an area to explore.

    
    

    Bulk of their experience needs to be in med device industry.

    
    

    Regulatory frameworks

    
    

    Quality leadership, management rep

    
    

    Extensive leading inspections and other standard quality processes. 

    
    

     

    
    
  
  

  • Original Job Description:

    
    
  
  

  •  

    
    
    

    • Minimum required Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

    • Minimum required Experience: Minimum of 15 years of experience within FDA-regulated medical device manufacturing, with an extensive focus on QMS compliance, inspection readiness, internal audit, CAPA, and process/continuous improvement.

    • Technical & Operational Requirements:

      
      

      • Deep subject matter expertise in QMSR, FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable global medical device quality system requirements.

      • Detailed knowledge of risk management, ISO 14971, PFMEA, root cause analysis, CAPA, nonconformances, and quality notification processes.

      • Demonstrated Front Room and Back Room audit expertise, including inspection strategy, communication flow, request management, SME preparation, evidence review, and real-time inspection support.

      
      

    • Leadership & Coaching Requirements:

      
      

      • Experience serving as a Management Representative or in an equivalent quality leadership role with accountability for QMS effectiveness, management review, and health authority or Notified Body inspection readiness.

      • Extensive experience leading or supporting regulatory inspections, including FDA inspections and Notified Body audits, in complex manufacturing or global matrix environments.

      • Demonstrated coaching capabilities to help teams translate regulatory and QMS requirements into sustainable daily practices.

      
      
    
    

    Preferred Qualifications & Skills:

    
    

    • Preferred Education: Master’s degree in Engineering, Life Sciences, or a related technical field.

    
    

    nonconformances, and quality notification processes.

  
  

  • Demonstrated Front Room and Back Room audit expertise, including inspection strategy, communication flow, request management, SME preparation, evidence review, and real-time inspection support.

  
  
  

• Leadership & Coaching Requirements:

  
  

  • Experience serving as a Management Representative or in an equivalent quality leadership role with accountability for QMS effectiveness, management review, and health authority or Notified Body inspection readiness.

  • Extensive experience leading or supporting regulatory inspections, including FDA inspections and Notified Body audits, in complex manufacturing or global matrix environments.

  • Demonstrated coaching capabilities to help teams translate regulatory and QMS requirements into sustainable daily practices.

  
  

Preferred Qualifications & Skills:

• Preferred Education: Master’s degree in Engineering, Life Sciences, or a related technical field.

Position Details:

• Location: Onsite at the Philips Ultrasound manufacturing facility in Reedsville, PA.