MedTech Quality & Compliance Director - QMS Leader

Philips Iberica SAU; Colorado Springs (CO); On-site; USD 162,000 - 258,000; Full time

Job summary

Philips seeks a Director of Quality and Compliance to lead the IGTD quality systems team, ensuring an effective QMS and regulatory harmony across sites. You will advise senior leadership, drive KPI-based performance improvements and align quality initiatives with business goals.

In this role, you will champion quality system simplification, manage audits/CAPA processes, and report on quality metrics to executives.

Qualifications

• Minimum 10+ years' experience in global, FDA regulated medical device environments.
• Proven leadership of diverse quality teams in multiple aspects of Quality (QMS, CAPA, Change Management, audits).
• Experience with KPI monitoring to drive performance and process improvement.
• Knowledge of global medical device regulations and standards (FDA, ISO13485, ISO14971, EUMDR).
• Strong collaboration and stakeholder management across an organization.
• Bachelor’s degree required; Master’s preferred.

Responsibilities

• Lead, manage and develop the Image Guided Therapy Devices quality systems team; drive engagement.
• Oversee operation and evolution of the QMS; ensure regulatory and policy compliance.
• Advise senior leadership on quality matters; align QMS programs with business objectives.
• Enforce simplification/harmonization of quality systems across sites; establish Management Review process.
• Provide strategic quality leadership as part of cross‑functional leadership teams.

Skills

Quality leadership

QMS implementation

CAPA management

FDA compliance

Regulatory knowledge

Education

Bachelor's degree in Quality, Life Sciences, Engineering or similar

Master's degree in business, management or quality (preferred)

Job description

Philips seeks a Director of Quality and Compliance to lead the IGTD quality systems team, ensuring an effective QMS and regulatory harmony across sites. You will advise senior leadership, drive KPI-based performance improvements and align quality initiatives with business goals.

In this role, you will champion quality system simplification, manage audits/CAPA processes, and report on quality metrics to executives.