Quality Assurance Specialist

BlueSnap, Inc; Frankfurt; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in energy-based medical devices is seeking a Quality Assurance (QA) Specialist in Frankfurt. The role involves ensuring compliance with quality standards and regulations while managing quality systems and processes. Candidates should have a relevant degree and at least 5 years of experience in quality assurance, preferably in the medical device industry.

Qualifikationen

• At least 5 years in quality positions, preferably in Medical Device/Pharmaceutical industry.
• Familiar with ISO 13485, EU MDR 2017/745 standards.
• Certification as an internal auditor is an advantage.

Aufgaben

• Handling Quality aspects: CAPAs, Non-conformance investigations, audits.
• Updating and writing procedures.
• Managing suppliers’ qualifications and maintaining quality agreements.

Kenntnisse

Documentation skills

Project management

Fluency in English

Fluency in German

Ausbildung

BSc in Life science/Bio Medical/Electronics/Machine Engineering

Jobbeschreibung

About Lumenis

At Lumenis, our commitment to excellence and innovation is driven by the energy of more than 1,000 professionals worldwide. This allows us to deliver groundbreaking innovations in the ophthalmology and aesthetic fields and to be recognized as the undisputed world leader in energy-based medical devices.

Headquartered in Israel, we are a truly innovative and international organization with a solid global footprint in developed as well as emerging markets, such as the United States, Germany, United Kingdom, China & Hong Kong, Japan, India, Australia, Korea, Singapore, and Taiwan.

About the role

The Quality Assurance (QA) Specialist ensures that medical devices meet regulatory and company quality standards through the development, implementation, and maintenance of quality systems. This role supports compliance with applicable regulations (such as FDA 21 CFR Part 820, ISO 13485, and MDR) and is critical in supporting product development, manufacturing and post-market surveillance activities.

Key Responsibilities

• Handling Quality aspects: CAPAs, Non-conformance investigations, SCARS, Internal and External audits, etc.
• Updating and writing procedures
• Handling training process
• Managing suppliers’ qualifications and maintaining quality agreements

Requirements

• BSc in Life science/Bio Medical/Electronics/Machine Engineer or other Quality relevant degree
• Experience of at least 5 years in quality positions, preferable from Medical Device/ Pharmaceutical industry
• Familiar with applicable standards and regulations: ISO 13485, EU MDR 2017/745
• Fluent English and German (writing and verbal)
• Strong documentation skills
• Basic computer skills
• Able to manage multiple projects and meet deadlines independently
• Certification as an internal auditor – advantage
• Hybrid work, can work remotely 2-3 days a week
• Must be located at the Frankfurt metropolitan area, up to 2 hours away from our offices