20 beste Stellen als documentation specialist in hamburg, hh – aktuell auf Personalsuche

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R&D Specialist Reprocessing Execution (m/f/d)

Olympus Europa SE & Co. KG -
Hamburg

Jetzt bewerben

Details zur Stelle

Festanstellung
vor 7 Tagen

Leistungen

Kostenloser Parkplatz
Firmenfahrrad-Leasing
Employee Assistance Program
Kostenfreies oder vergünstigtes Deutschland-Ticket

Qualifikationen

Mikrobiologie
Doktorat
Microsoft Office
Mikrobiologie
Master
Bachelor
Reinigung
Projektleitung
Führungserfahrung

Vollständige Stellenbeschreibung

Olympus Winter & Ibe GmbH (OWI)Chief Technology Officer

Type of employment:

Permanent employment

Function:

Research & Development

Location:

Hamburg

Reference Number:

80227713-29062026

Website:

https://www.olympus-oste.eu

As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Your Responsibilities

Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities related to reprocessing and sterilization.
Lead cleaning, disinfection, and sterilization validation activities according to applicable standards and regulations while ensuring high-quality documentation.
Serve as the technical contact person for peers and subject matter expert for reprocessing and sterilization-related topics.
Build and maintain expertise in applicable regulations, standards, and requirements (e.g., ISO 17664 series, MDR 2017/745, ANSI/AAMI ST98, relevant FDA guidance documents), translating them into streamlined internal processes and documentation.
Lead third-party collaborations with external testing laboratories regarding cleaning validation, disinfection efficacy, and sterilization validation studies.
Collaborate with cross-functional teams across Regulatory Affairs, Quality, Risk Management, Manufacturing Engineering, and R&D.
Communicate validation strategies, study outcomes, and technical recommendations to relevant stakeholders (e.g., Regulatory Affairs, Quality, Risk Management, Manufacturing).
Support investigations, change management activities, CAPAs, and continuous improvement of QMS processes and testing strategies.
Participate in internal and external audits and provide expert support for technical and regulatory questions.

Your qualification

Bachelor’s, Master’s in Medical Engineering, Microbiology, Natural Sciences, or equivalent. PhD in a relevant field is advantageous and will be preferred.
2-5 years of relevant experience in medical device reprocessing, sterilization, microbiology, or a related regulated environment.
Strong knowledge of ISO 17664 series, MDR 2017/745, and medical device development processes.
Experience with cleaning validation, sterilization validation, and reusable medical device reprocessing will be preferred.
Experience with change management, non-conformities (NCs), and CAPAs.
Strong cross-functional understanding, project leadership capabilities, and solution-oriented working style.
Ability to interpret technical drawings and mechanical designs
Good verbal English skills; a clear communication style will be appreciated.
Good written English skills; experience with documentation of scientific results is preferred.
Good knowledge of MS Office.

Your benefits

30 days of annual leave
Up to 60% mobile work possible + flexible work time model with overtime compensation
Holiday and Christmas bonuses
Corporate benefits discounts for employees
Comprehensive company pension scheme and capital-forming benefits
Company restaurant with live cooking and healthy food (subsidized)
Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
Various subsidized company sports groups and access to the inhouse company gym

About Olympus

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
For more information, visit
www.olympus-europa.com
and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.

Further information:

Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.
We warmly encourage all who wish to bring their talents to Olympus to apply.

More reasons to join our team

Jetzt bewerben

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