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Quality Assurance and Regulatory Affairs · Kleve · Hybrid

Manager Quality & Vigilance (m/f/d)

Become a Manager Quality & Vigilance (m/f/d)

📍 Location: Kleve, Germany (NRW)

Shape quality. Take ownership. Make a difference for patients.

Are you looking to do more than just manage — to truly make an impact?
Do you enjoy building structures, developing teams, and ensuring the highest quality and safety standards are met?

Then Medline is the right place for you.

About Medline – improving healthcare together

With over 43,000 employees worldwide, Medline is one of the leading companies in the healthcare industry.

Our mission is clear:

  • Improve patient care

  • Deliver innovative, practical medical products

  • Provide sustainable and safe solutions for clinical environments

With us, you will work close to real-world practice while being part of a globally connected organization.

Collaborative. Reliable. On equal footing.

Your role as a leader

As a Manager Quality & Vigilance (m/f/d), you will take on a key role within our QARA team in the EMEA region.

You will actively shape the future of our Complaint Handling and Vigilance function — strategically, operationally, and most importantly, together with your team.

👉 You don’t just manage processes – you develop people and structures.

🎯 Your mission – where you make a real impact

  • Lead, develop, and coach a team of Complaint & Vigilance Specialists

  • Own the end-to-end complaint handling process — from intake to evaluation and reporting

  • Ensure full compliance with all regulatory requirements (e.g., EU MDR)

  • Continuously improve processes, tools, and workflows

  • Collaborate closely with cross-functional stakeholders (QA, Regulatory, Clinical, Product Management)

  • Act as a key contact for authorities and support audits and inspections

  • Establish and monitor relevant KPIs to ensure transparency and high quality

👉 In short:
You ensure that quality, safety, and compliance are embedded throughout the entire product lifecycle.

⭐ What you bring

  • Degree in a scientific, technical, or medical field

  • Several years of experience in the medical device industry, ideally in Complaint Handling / Vigilance

  • Leadership experience, ideally across multiple locations

  • Strong knowledge of relevant regulations (e.g., ISO 13485, MDR 2017/745)

  • Structured, analytical mindset and strong problem-solving skills

  • Excellent communication skills and confidence in interacting with authorities

  • Fluent English; additional languages are a plus

What sets you apart:
You take ownership, think entrepreneurially, and lead with clarity and empathy.

💙 Why you’ll enjoy working at Medline

We believe that leadership is built on trust, development, and collaboration.

Here’s what you can expect:

Ownership & Impact

You actively shape processes, structures, and your team.

International Collaboration

Work in a globally connected environment with high relevance.

Personal & Professional Development

We actively support your growth as a leader.

Attractive Benefits

  • Flexible working arrangements

  • 30 days of vacation

  • Company pension scheme

  • Additional benefits of an international company

Purpose-driven role

Your work directly contributes to patient safety.

💬 Ready for the next step in your leadership career?

We look forward to getting to know you.

Join Medline in Kleve and help shape the future of patient safety.

Your leadership. Our trust. Shared impact.

Department
Quality Assurance and Regulatory Affairs
Locations
Kleve
Remote status
Hybrid

Kleve

Our Medline Success Factors

Do you recognise yourself in these factors? Then Medline might be a great place for you to work! We believe that the way in which people approach their work, collaborate with their colleagues and fulfil the needs of our customers are just as important as their technical and professional skills, and play a big role in professional and personal success.

Quality Assurance and Regulatory Affairs · Kleve · Hybrid

Manager Quality & Vigilance (m/f/d)

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