Quality & Compliance Coach - Manager

Location: Northern

# Quality & Compliance Coach - Manager Philips Reedsville 3 maanden

Gepubliceerd 11 uur geleden
· Opportunity f indicatie €100 /uUren 40 u/wStart 31 Oct 2026

Duur 3 maanden

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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…