Senior QM R&D Engineer - Risk Management

Ambu A/S; Augsburg; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Benefits dieser Stelle

Opportunities for personal and professional development

Dynamic international work environment

Wide range of employee benefits

Zusammenfassung

Ambu A/S is seeking a Senior QM R&D Engineer to drive quality and compliance initiatives within their medical device development team in Augsburg, Germany. This role focuses on leading Risk Management efforts for innovative products, ensuring adherence to global standards.

The ideal candidate will possess a BSc/MSc and a minimum of 3 years of experience within regulated industries, combined with strong communication and quality management skills. Ambu offers a collaborative environment with numerous development opportunities.

Qualifikationen

• 3+ years of experience in a regulated industry (medical devices or pharma).
• In-depth knowledge of relevant standards.
• Strong communication skills and collaborative approach.

Aufgaben

• Drive Risk Management for both new and existing products.
• Be the Quality Management partner for global R&D projects.
• Support CAPA activities and non-conformities.

Kenntnisse

Quality Management

Risk Management

Regulatory Compliance

Communication Skills

Ausbildung

BSc/MSc in a relevant field

Tools

ISO 14971

ISO 13485

EU MDR

MDSAP

UK MD

Jobbeschreibung

Senior QM R&D Engineer – Risk Management

Location: Ballerup, Denmark / Augsburg, Germany. Employment Type: Full‑time. Req ID: 10344.

Shape the Future of Medical Innovation

Are you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle—especially in Risk Management? If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with Ambu.

Why Join Ambu?

Ambu is a global leader in medical device innovation, dedicated to improving patient care. As a (Senior) QM R&D Engineer, you’ll be part of a collaborative, forward‑thinking team that values integrity, innovation, and impact.

Key Responsibilities

• Driving Risk Management for both new and existing products
• Being the Quality Management partner for global R&D projects
• Carrying out Life Cycle Management activities, including design changes and post‑market surveillance
• Supporting non‑conformities and CAPA activities

Candidate Profile

• A BSc/MSc in a relevant field and 3+ years of experience in a regulated industry (medical devices or pharma)
• In‑depth knowledge of standards such as ISO 14971, ISO 13485, EU MDR, MDSAP, and UK MD
• Experience as a Quality Engineer in Research & Development projects of medical devices
• Strong communication skills and the ability to translate quality requirements into actionable strategies
• A collaborative, open‑minded approach with the confidence to drive and adapt in a fast‑paced environment

Benefits

• A great team that thrives on collaboration and values different perspectives and fosters innovation
• Opportunities for personal and professional development
• A dynamic, diverse and international work environment
• A wide range of employee benefits—professional, social, and financial

As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.