Job Search

Qualitätsmanager Zentraleuropa Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Aufgaben Qualitätsmanagement am Standort, einschließlich der Leitung des Teams und der Prozesse. Enge Zusammenarbeit mit den Direktoren für Regulatory Affairs und Qualitätsmanagement bei Beschwerden und Untersuchungen von Fehlern, um die Ursache und dauerhafte Korrekturmaßnahmen zu bestimmen. Unterstützung und Mitwirkung bei der Analyse von Feldausfällen und Produktionsfehlern, um Produkt und Prozesse zu verbessern. Förderung und Pflege einer Kultur kontinuierlicher Verbesserung, einschließlich Fertigungs- und Konstruktionsprozesse sowie Dokumentationen im gesamten Unternehmen. Sicherstellung der Einhaltung der Produkt-Risikomanagement-Dokumentation gemäß ISO 14971. Unterstützung des Beschaffungsteams bei der Entwicklung und Aufrechterhaltung der Lieferantenqualität, einschließlich der Pflege von Prozessen. Profil Master- oder Bachelor-Abschluss in Ingenieurwissenschaften mit mehreren Jahren praktischer Erfahrung im Qualätsmanagement oder ähnlichen Tätigkeiten in einer Fertigungsumgebung. Umfangreiche Erfahrung in der Umsetzung kontinuierlicher Verbesserungen in einer schlanken Fertigungsumgebung. Erfahrung in der Leitung/Überwachung von Qualitäts-Technikern und Ingenieuren. Ausgezeichnete organisatorische Fähigkeiten, einschließlich der Fähigkeit, Lieferergebnisse und Zeitpläne für die Umsetzung zur Erreichung von Projektzielen zu verwalten. Bereitschaft und Fähigkeit zu nationalen und internationalen Reisen, falls erforderlich. Ausgezeichnete schriftliche und mündliche Kommunikationsfähigkeiten in Deutsch und Englisch. Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2

Regulatory Affairs Spezialist Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Aufgaben Leitung der Implementierung von Qualitätsmanagementsystemkomponenten mit Schwerpunkt auf der Einhaltung regulatorischer Vorschriften, einschließlich MDR 2017/745, ISO 13485 und ISO 14971 Verwaltung von Projekten und Aktivitäten zur Verbesserung von Produkten und Prozessen aus regulatorischer Sicht Kontinuierliche Überwachung und Sicherstellung der Einhaltung regulatorischer Anforderungen, insbesondere in Europa, der Schweiz und dem Vereinigten Königreich Überwachung des Corrective and Preventive Action (CAPA)-Systems, Verfolgung von Rückrufen und Field Safety Corrective Actions (FSCA) zur Behebung von Compliance-Problemen Teilnahme an Risikobewertungsaktivitäten wie uFMEA zur Identifizierung und Verwaltung potenzieller Risiken im Zusammenhang mit unseren Produkten Enge Zusammenarbeit mit dem Quality Director Europe, um sicherzustellen, dass alle Dokumentationen den relevanten regulatorischen Standards entsprechen Unterstützung bei der Untersuchung von Haftungsansprüchen und der Sammlung von Dokumentationen bei Bedarf   Profil 2+ Jahre Berufserfahrung im Bereich Regulatory Affairs oder Qualitätsmanagement im Zusammenhang mit Medizinprodukten Fundierte Kenntnisse der regulatorischen Anforderungen (z. B. MDR, ISO 13485 & ISO 14971) IT-Kenntnisse in MS Office Starke Kommunikationsfähigkeiten, gute Organisationsfähigkeiten, analytisches Denken und ein hohes Maß an Zuverlässigkeit Fließende Englisch- und Deutschkenntnisse sind von Vorteil Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750   #LI-MC2

eQMS Manager Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Unser Kunde sucht derzeit einen erfahrenen eQMS-Systemmanager zur Verwaltung der Implementierung, Optimierung und kontinuierlichen Verbesserung des eQMS im gesamten Unternehmen. Aufgaben Lebenszyklusmanagement der Qualitätsmanagementssoftware, einschließlich Installationen und Konfiguration sowie Entwicklung neuer Workflows für Tests und Validierung. Schulung von Benutzern und lokalen Systemadministratoren sowie Verwaltung von Zugriffen und Rechten für Benutzer. Enge Zusammenarbeit mit dem Softwareanbieter zur Lösung von Problemen bei deren Auftreten, Aktualisierung oder Implementierung zusätzlicher Funktionen im System. Entwicklung von Berichten basierend auf den Anforderungen der Endbenutzer und des Managements, um effiziente Echtzeitberichterstattung zu ermöglichen. Enge Zusammenarbeit mit RA & Qualität, um die Einhaltung der aktuellen Standards und Vorschriften sicherzustellen. Profil Master- oder Bachelor-Abschluss in Ingenieurwissenschaften mit Erfahrung in der Systemadministration. Vorherige Erfahrung mit MasterControl im Bereich MedTech oder einem ähnlichen Bereich ist wünschenswert. Kenntnisse der HTML-Sprache wären von Vorteil. Verständnis der branchenspezifischen Anforderungen und Trends zur Sicherung der Datenintegrität, einschließlich der FDA-Leitlinien für die Industrie zu "Datenintegrität und Einhaltung der cGMP". Erfahrung und Fähigkeiten im Projektmanagement sowie starke Problemlösungsfähigkeiten. Ausgezeichnete Kommunikationsfähigkeiten und Aufmerksamkeit für Details. Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

(Senior) HR Manager – Northern Bavaria (hybrid flexibility) Are you an experienced Human Resources Manager with strong people skills, and looking for the next step in your career? Support a globally leading Medical Device manufacturer and oversee the HR activities for Germany, such as workplace & and succession planning, and identifying talents through recruitment! Your tasks: Report to the HR Director International and manage a small team supporting you across recruitment, employee contracts, and onboarding. Proactively develop talent and address performance issues. Create and develop leadership bench strength and enhance leadership team effectiveness. Recruit top talent to build diversity, fill talent gaps, and build bench strength. Vendor relationship management with recruitment agencies (you will get to work with me and my colleagues who have supported the company with over 30 filled positions in the last couple of years). Oversee the use of systems to ensure accurate data is stored and available to the business. Assign roles, duties, and methods of operation to the German staff in order to provide them with a customer focused and attentive HR service. Lead and inspire your team to strive for operational excellence. Ability to educate leadership outside of Germany on obligations for managing employment in Germany. Benefits: Competitive bonus. 30 days of vacation. Friendly and supportive environment and a lot of space for further development! Hybrid flexibility (you would for example, be happy to visit the office twice a week) What is expected: Minimum of 5 years’ previous Human Resource experience. Fluent speaker in English and German. An expert in employment law applicable to Germany. Strong commitment to and interest in employee relations and communication. Flexibility to adjust priorities to changing business environment. Confidence and ability to influence others, facilitate processes, and coach/advise managers.  Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. Dominika.Wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

Regulatory Affairs Specialist Overview With roots dating back to 1930s, our client is dedicated to specializing in high-quality endoscopy products. With them, you can enjoy the personal benefits of creative freedom, collaboration within a collegial team, and the security of our international group structure as well as experience innovation, access tailored training for professional and personal growth, and work in modern, ergonomic spaces with additional perks. Would you like to elevate your career by expanding expertise in technical documentation and regulatory affairs, engaging with a diverse product portfolio? This is your chance! Tasks Seamlessly integrate regulatory requirements and standards into diverse product portfolios, overseeing the creation of product files for technical documentation and independently managing projects Compile international approval documents in accordance with country-specific regulations, collaborating closely with relevant departments to address technical queries Foster trustworthy relationships with customers and suppliers while identifying global regulatory requirements Your profile Apprenticeship or vocational training as an industrial clerk, complemented by additional training and interest in technology and medical products or equiavalent Experience in MedTech industry or in areas such as Regulatory Affairs, Quality Management, Technical Documentation, Sales or Development Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Our client is a global respiratory diagnostics leader and is currently looking for an HR Manager Germany. Job Summary   Reporting to the HR Director International, the HR Manager Germany will have a passion for people and culture In this role, the HR Manager Germany will be responsible for delivering both HR operational excellence and driving the people and culture strategy HR Ownership of people and culture for Germany Member of the Hochberg Management responsible for driving alignment and maximizing efficiencies across the businesses The role is critical in executing people initiatives, providing great internal customer support, and driving HR functional excellence and process improvement The role will be based in Wuerzburg area, Germany, Expectation to be present at on-site. Home office by exception with occasional travel to other office´s sites in Germany.   Required Qualifications: Education: Associates or Bachelors degree preferred Fluent English speaker Experience: 5 + years of Human Resource experience in progressively more responsible positions Ability to Chair works council relationship in a way that enables business objectives to be achieved with the support and engagement of the works council and in compliance with local regulations Ability to educate leadership outside of Germany on obligations for managing employment in Germany Professional presence; polished communication skills and proven ability to effectively collaborate with senior level management. Self-motivated and self-disciplined. Excellent listening and assessment skills. Confidence and ability to influence others, facilitate processes, and coach/advise managers. An expert in employment law applicable to Germany Strong commitment to and interest in employee relations and communication Ability to lean in an environment of constant change and make progress during times of ambiguity. Flexibility to adjust priorities to changing business environment Demonstrates a high degree of confidentiality in interpersonal interaction   Objective:  To provide end to end HR service for employees in Germany within the framework of local regulations and HR policies and practises   Essential Duties (Primary Tasks):   Business Partner to Senior Leaders based in Germany: Key Roles include Hochberg GM, Operations Director, IT Director & DACH commercial director - Partner closely with business leaders to: Enhance personal effectiveness, Act as a confidant and coach, Offer a balanced perspective and offer insights, Manage the blind spots, Provide advice and counsel, Set the business leader up for success, Provide consulting, advice and coaching to business leaders - Liaise with US based business partners on global organization changes and HR programs.   Enable business objectives through their people Support implementation of MBO’s (growth and business objectives), Organizational Design, Prepare leaders to manage the organization through change, Achieve organizational design to support business growth, Workforce Planning/Human Capital Planning, Succession Planning, Proactively manage transition for anticipated attrition   Leadership Development Proactively develop talent and address performance issues, Create and develop leadership bench strength, Enhance leadership team effectiveness, Identify talent pipeline and proactively manage development   Employee Relations and Works Council Chair Works Council for Germany to be compliant with applicable regulations and proactively manager the employee relations climate to enable business to deliver business Change Manage individual and collective employee relations issues for Germany Responsible for resolution of complex individual ER issues and investigations including governance, management and negotiation of employee terminations in line with organization culture and appropriate assessment of legal risk. Educate managers and leaders outside Germany on how to achieve people objectives within local regulations Responsible for ER delivery of change projects and business transformation. Support the business to achieve objectives within a framework of corporate policy and legal compliance. Proactively managed the employee relations climate in Germany line with evolving employment law environment with review of HR policies and development of management training   Talent Acquisition Support hiring managers to fill reqs based in Germany, Recruit top talent to build diversity, fill talent gaps and build bench strength Vendor relationship management with recruitment agencies   Total Rewards Manage vendor relationship and benefit programmes for Germany. Recommend changes in line with external environment and any regulatory developments   HR Operations Oversee use of systems to ensure accurate data is stored and available to the business Oversee personnel file management to ensure accurate retention of data and information is available to the business   Line Management Assign role and responsibilities and ways of working to ensure a customer centric and responsive HR service to the German team. Motivate and lead your team in a way that cultivates operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to improve results; serve as a role model in creative thinking and in focusing on quality work. Cascade organizational goals through the function/work area to the individual level and ensure individuals understand how they are a part of business success. Establish goals and achieve results within your team, holding yourself and others accountable for results. Reporting:  Reports to International HR Director Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic sanela@adaptivelifescience.com +4915123483158  Mobile #LI-SH2 #LI-Hybrid  

Our client is a global respiratory diagnostics leader and is currently looking for a Senior Specialist HR Payroll. Job Summary: • Operational payroll standards and processes have to be kept on high professionel level to ensure positive stakeholder experience • Responsible for accuracy of payroll data, and researches data integrity issues. • Serve as the primary point of contact for employee payroll questions. • Responsible for ensuring a smooth and professional payroll process in order to satisfy the customers needs in line with Vyaire processes • First contact point for managers and employees for payroll related questions • Support returning HR processes • Member of the Global Payroll Team as well as working closely with the members on the objectives Required Qualifications: Education: Completed apprenticeship Further training in HR (payroll specialist) preferred Fluent German and English speaker Minimum of 5 years of German payroll experience - Experience with external payroll providers Knowledge: Profound current knowledge of german payroll processes as well as tax and social security law and retirement funds Knowledge of a common payroll programme (preferably Sage) Good problem-solving abilities, strong understanding of numbers and analyticalskills High level of customer orientation, sense of responsibility and initiative Hands-on experience with Office 365 package ESSENTIAL DUTIES AND RESPONSIBILITIES: Independent and autonomous preparation of payroll accounting including all preparatory and follow-up activities, Independent execution of the monthly payroll including transmission of the data to the social security institutions, tax office and financial accounting Clarification and evaluation of payroll tax and social security issues Comprehensive recording and maintenance of personnel master data Taking care of absences, especially maternity leave, parental leave, illness, including communication with health insurance companies . Maintenance and monitoring of absences including certification to health insurance companies Social security assessment of special employments (e.g. interns, students, mini[1]jobbers, partial retirement) Preparation and follow-up, monitoring and administrative implementation of special employment relationships (in particular maternity/parental leave and partial retirement) including insurance coverage Executing of capital-forming benefits, direct insurance, deferred compensation and retirement provisions Processing of enquiries from social security institutions, the tax authorities and other authorities and institutions Support with necessary monthly, quarterly and annual financial reporting including preparation and reconciliation of data for and with accounting (salary postings, personnel provisions, etc.) Coordination, supervision, pre and post processing of internal and external audits by auditors, tax authorities and social security institutions Close cooperation with the local personnel departments of our internal client companies as well as interface with local financial accounting departments Continuous further development of payroll-relevant processes Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic sanela@adaptivelifescience.com +4915123483158  Mobile #LI-SH2 #LI-Hybrid

CAD/CAM Engineer Are you searching for a new challenge in the field of CAD/CAM Engineering? Join our client, a pioneering MedTech company, based close to Berlin who specializes in the manufacturing of high-quality implantable devices & instruments for orthopaedic surgery. Focuses: CAD preparation for CAM programming and measurement programs Computer simulation of forming processes Working with designs and translating it into machining processes Creation and maintenance of development-related documentation, according to the requirements of the Quality System Experience required: Completed training as a technician, an apprenticeship in toolmaking or a degree in a technical field Ideally 3-5 years of professional experience in CAD/CAM Experience with 3D CAD/CAM, preferably using Siemens NX 11 / QForm VX 8.1.3 Fluency in English and German If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1  #LI-Hybrid