Quality Management Specialist

Hologic, Inc.; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A medical device company in Berlin is looking for a Quality Management Specialist to contribute to quality processes that ensure safe medical devices. You will maintain the QMS, develop training, and oversee CAPA processes. Candidates should have in-depth knowledge of ISO 13485 and EU MDR, with a background in Quality positions. Strong skills in communication, German, and English are essential. The role offers a competitive salary and benefits in a collaborative environment.

Leistungen

Competitive salary

Health insurance

Career development opportunities

Qualifikationen

• In-depth knowledge of ISO 13485, MDSAP, EU MDR 2017/745.
• Strong level of experience in Quality positions within the medical device sector.
• Practical experience with CAPA and continuous improvement.
• Fluent in German and strong in English.

Aufgaben

• Maintain and further develop QMS in line with EN ISO 13485 and MDSAP.
• Create, update, and improve procedures, forms, and training materials.
• Lead and oversee CAPA initiation and processing.
• Communicate with notified bodies and regulatory partners.

Kenntnisse

In-depth knowledge of ISO 13485

Strong experience in Quality positions

Experience with CAPA

Strong communication skills

Fluent German

Strong English

Ausbildung

Technical Bachelor’s or Master’s degree

Tools

Advanced Outlook

Word

PowerPoint

Basic Excel

Document management systems

Oracle

Jobbeschreibung

Quality Management Specialist

Are you motivated by contributing to safe and compliant medical devices through robust quality processes?

Do you enjoy working with standards such as ISO 13485, MDSAP and EU MDR and translating them into practical procedures?

This is your chance to contribute to impactful work in the medical device industry, where your expertise will directly support our mission of improving lives through innovation and quality.

What To Expect:

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review
• Support internal and external audits and change management
• Monitor and report key quality metrics and trends
• Communicate with notified bodies, authorities, and regulatory partners
• Monitor and interpret regulatory standards and changes
• Support risk management (e.g., ISO 14971), supplier quality, nonconformance and complaint handling
• Contribute to management reviews and continuous improvement initiatives

What We Expect:

• In-depth knowledge of ISO 13485, MDSAP, EU MDR 2017/745
• Strong level of experience in Quality positions within the medical device sector
• Practical experience with CAPA and continuous improvement
• Advanced Outlook, Word, PowerPoint; basic Excel
• Experience with document management systems and ideally Oracle
• Technical Bachelor’s or Master’s degree
• Quick to learn new processes and tools
• Strong communication and interpersonal skills; able to coordinate cross-functional teams
• Able to prioritize and deliver in a results-driven environment
• Excellent attention to detail and accuracy in documentation and data review
• Fluent German and strong English (written and spoken); other languages a plus.

Why Hologic?

• Work on impactful projects that make a difference in the medical device industry.
• Develop your skills and grow your career in a supportive and collaborative environment.
• Competitive salary and benefits package, including health insurance.

Apply today!