Senior Manager Quality Assurance

Panda International; Utrecht; On-site; EUR 120,000 - 180,000; Full time

Job summary

Panda International in Utrecht, Netherlands, seeks a Senior Manager of Quality Compliance, EMEA (Medical Devices) to own quality strategy, compliance, and QMS performance across the region. You will oversee QMS, Supplier Quality, and Divisional QA, ensuring alignment with EU MDR 2017/745, ISO13485, and global standards while driving continuous improvement.

This role requires leading cross‑functional teams across multiple sites, influencing senior stakeholders, and guiding regulatory readiness.

Qualifications

• 10+ years in Medical Device Quality with Class I/II preferred.
• Deep knowledge of EU MDR, ISO13485 and end-to-end QMS.
• Proven leadership across multiple teams and locations.
• Strategic thinker with hands-on execution.

Responsibilities

• Own quality strategy, compliance, and QMS performance across EMEA.
• Lead QMS, Supplier Quality, and Divisional QA teams.
• Ensure compliance with EU MDR 2017/745, ISO13485, and global standards.
• Drive continuous improvement and operational excellence across multiple sites.
• Lead audits with Notified Bodies and authorities.

Skills

Team leadership

EU MDR

ISO13485

QMS management

Regulatory readiness

Design controls

DHF

Lifecycle quality

Job description

Senior Manager of Quality Compliance, EMEA (Medical Devices)

We are looking for a senior leadership role with full ownership of quality strategy, compliance, and QMS performance across the EMEA region. The role will lead QMS, Supplier Quality, and Divisional QA teams, ensuring compliance with EU MDR 2017/745, ISO13485, and global standards, while driving continuous improvement and operational excellence across multiple sites.

Key Focus Areas

• Leadership of regional Quality & Compliance strategy across EMEA
• Oversight of QMS (CAPA, audits, change control, management review)
• Supplier quality and finished goods compliance
• Design controls, risk management (ISO14971), and product lifecycle quality
• Cross‑functional collaboration with RA, R&D, Operations, and global stakeholders
• Leading audits (Notified Bodies, authorities, customers) and regulatory readiness
• Driving harmonisation and simplification of QMS across sites

Qualifications

• 10+ years in Medical Device Quality (Class I/II preferred)
• Strong expertise in EU MDR, ISO13485, and end‑to‑end QMS
• Proven leadership experience across multiple teams and locations
• Track record in building quality culture and influencing senior stakeholders
• Strategic mindset with hands‑on execution capability
• Expertise with product development activities, including DHF, design controls