Director, Quality & Compliance-Image Guided Therapy Devices

Philips

Medical Technology

Colorado Springs, CO - USA

Manager / Team Leader

Experteer Overview

In this role you will lead the Image Guided Therapy Devices quality systems program, driving harmonization and simplification of QMS across the business. You will partner with senior leadership to shape the strategic vision for quality, regulatory and compliance programs and ensure robust processes, audits, CAPA and management reviews. You will enable high-quality products and customer satisfaction by embedding standardized tools and reporting across sites. This is a cross-functional, impact-driven leadership opportunity with a focus on regulatory excellence and process improvement.

Compensation / Benefits

comprehensive Philips Total Rewards benefits program
generous PTO
401k with up to 7% match
HSA with company contribution
stock purchase plan
education reimbursement

Responsibilities

Lead, manage and develop the IGTD quality systems team and foster an engaging, inclusive culture
Oversee the QMS operation and evolution to maintain regulatory and standard alignment
Drive quality process/tool introduction, change management and CAPA/audit programs
Implement and improve Management Review processes and KPI reporting
Advise senior leadership on quality strategy and align QMS with business objectives
Harmonize quality systems across multiple sites and establish cross-functional governance
Represent quality on the Business Category Leadership Team and partner across functions to address quality challenges
Ensure product quality and customer satisfaction through robust processes and metrics

Key requirements

10+ years in global, FDA-regulated medical device environments
Proven leadership of diverse quality teams across multiple sites in a large, matrix organization
Experience with QMS implementation, simplification and standardization
Strong background in CAPA, Change Management, and internal/external audits
Knowledge of global medical device regulations and standards (FDA, ISO13485, ISO14971, EUMDR)
Ability to monitor KPIs and drive performance improvement
Strong communication and stakeholder management across all organizational levels
Bachelor degree in a relevant field; Master degree strongly preferred

collaborative leadership strategic thinking influencing and stakeholder management Quality Management System (QMS)CAPA Change Management

Description

In this role you will lead the Image Guided Therapy Devices quality systems program, driving harmonization and simplification of QMS across …

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