Clinical Auditor Stellenangebote

Job am 20.01.2026 bei Jooble gefunden SGS

Global Head of Delivery and Operations

• Meinerzhagen Führungs-/ Leitungspositionen [. .. ] of Role Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. This role ensures the [...]

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[...] effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. Oversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. The role reports to the Head of Notified Body 1639. Key Accountabilities The role [. .. ] QMS requirements. Excellent interpersonal and stakeholder management skills. Strong organizational and change management capabilities. Strong commercial understanding and appreciation of the TIC industry. Experience in resource planning. Qualification as Lead Auditor or Product Assessor under EU MDR/ EU IVDR. Qualification as Final Reviewer and Decision Maker under MDR or IVDR. Experience in a Notified Body or equivalent regulatory organization. Experience Essential Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. [. .. ]

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Job am 14.01.2026 bei Jooble gefunden Merz Therapeutics

(Senior) Quality Assurance Manager GCP (m/f/d)

• Frankfurt am Main Work-Life-Balance [. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations-including requirements for IT systems used [...]

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[...] in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-[. .. ] Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]

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Job vor 2 Tagen bei Jobleads gefunden

Staff Supplier Quality Engineer (f/d/m) - Jobbird. com

• München, Bayern [. .. ] belonging where your unique viewpoint matters. By harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a [...]

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[...] global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, [. .. ] Six Sigma, Problem Solving, Statistical Tools) Knowledge of EU, FDA and related regulations including QSRs, (FDA 21 CFR 820) , ISO 13485, ISO 9001 and the EU IVDD Certified internal auditor ISO 9001 or ISO 13485 Experienced in working within multi-functional, multi-regional teams Fluent in German and English languages. Good computer skills which include Microsoft Applications, Databases and Web-based Tools. Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We [. .. ]

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Job vor 8 Tagen bei Jobleads gefunden

Head of Finance

• Rüti (ZH) , Zürich Rüti (ZH) Führungs-/ Leitungspositionen Overview As one of the fastest-growing providers of in-home healthcare, we combine world-class clinical standards with operational excellence and modern technology. Families trust us because we respond quickly, advocate for [...]

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[...] caregivers, and operate with integrity and reliability. We believe people receiving care at home deserve dignified, self-determined lives and that caregivers are heroes whose work must be supported and fairly compensated. Our mission [. .. ] and transactions with speed and precision. Ensure full compliance with Swiss statutory requirements (OR accounting, tax, VAT, regulatory filings) while optimizing for efficiency. Manage annual audits through flawless preparation, proactive auditor management, and data-driven documentation. Provide authoritative technical guidance on revenue recognition, leases, capitalization, cross-border matters, and group reporting topics. Team Leadership Capability Building : Build and lead a high-performing team of 10+ accounting professionals, attracting and developing top talent. Create a culture of ownership, analytical rigor, and [. .. ]

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Job am 24.01.2026 bei Jobleads gefunden

General Manger/ Operational Manager

[. .. ] Lead, mentor, and inspire multi-disciplinary teams across multiple sites. Develop senior leaders and managers to strengthen capability, performance, and succession planning. Ensure compliance with worker screening, training, [...]

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[...] supervision, and clinical governance requirements Foster a high performing, inclusive, and values aligned workplace culture. NDIS Compliance Sector Expertise Ensure full compliance with NDIS Practice Standards, restrictive practices requirements, and relevant legislation. Lead and manage preparation for NDIS certification and surveillance audits, including auditor engagement and corrective action planning Maintain operational readiness for audits and high-intensity service delivery. Proactively address sector specific challenges with practical, risk aware solutions. Operational Excellence Systems Oversee systems, processes, and workflows to ensure efficiency, scalability, and quality outcomes. Implement and monitor quality assurance, continuous improvement, and risk management [. .. ]

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Job am 23.01.2026 bei Jobleads gefunden

Software Medical Device Quality Engineer

• Wien [. .. ] edge AI-powered data analysis Services, that make it possible to standardize the process of skin imaging, objectify disease and treatment assessment, and to accelerate data collection and [...]

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[...] analysis in clinical trials and medical routine. We are growing and seeking new, experienced and hands-on team members who think outside of the box, deliver unique ideas and like to work in a fast-paced digital health and medical research environment. You are reliable, ambitious, your heart beats for clinical trials, digital [. .. ] development and regulatory filings Experience working with external manufacturing partners Desired Advanced Degree and Experience working in Pharmaceutical/ Biotech/ Device industry, Software Application Medical Device Engineering background preferred, Quality IT; Auditor certification. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team. Strong decision-making skills even in times of uncertainty. Responsible for continuous improvement on an ongoing basis to [. .. ]

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Job am 23.01.2026 bei Jobleads gefunden Global Head of Delivery and Operations • Meinerzhagen, Nordrhein- Westfalen Führungs-/ Leitungspositionen [. .. ] of Role Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. This role ensures the [...]

MEHR INFOS ZUM STELLENANGEBOT

[...] effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. Oversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. The role reports to the Head of Notified Body 1639. Key Accountabilities The role [. .. ] QMS requirements. Excellent interpersonal and stakeholder management skills. Strong organizational and change management capabilities. Strong commercial understanding and appreciation of the TIC industry. Experience in resource planning. Qualification as Lead Auditor or Product Assessor under EU MDR/ EU IVDR. Qualification as Final Reviewer and Decision Maker under MDR or IVDR. Experience in a Notified Body or equivalent regulatory organization. Experience Essential Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. [. .. ]

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Job am 22.01.2026 bei Jobleads gefunden

Quality Manager in Regulatory Affairs (f/m/d)

• Berlin [. .. ] in healthcareto date with 500, 000 participating women. Our mission is to make breast cancer screening more effective, measurable, and accessible. By enhancing early detection and ensuring [...]

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[...] outcomes backed by clinical evidence, were proud to contribute to national efforts focused on improving womens health. Founded in 2018 as the first company to emerge from Europes leading AI venture studio, Merantix, Vara has grown into an international team of 25 driven professionals. Our diverse team brings together entrepreneurs, healthcare experts, and technology [. .. ] ISO 14971) Familiarity with AI/ ML validation, software development workflows, and lifecycle management Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA Sa MD Guidance, IMDRF) Nice to have: Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus) Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001) Understanding of AI/ ML-specific regulatory requirements (e. g. , GMLP, EU AI Act) Prior experience in startup or scale-up environments Fluent in German (minimum B2-level) [. .. ]

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Job am 21.01.2026 bei Jobleads gefunden

Quality Assurance Auditor (all genders)

• Berlin Homeoffice möglich Flexible Arbeitszeiten Jobticket 30+ Urlaubstage Vermögenswirksame Leistungen Work-Life-Balance [. .. ] Agreements/ Verantwortungsabgrenzungsverträgen Sicherstellung der GMP-konformen Dokumentation im Rahmen der Qualitätssicherung Mitarbeit bei der kontinuierlichen Verbesserung von Qualitätssicherungsprozessen Enge Zusammenarbeit mit anderen Fachabteilungen zur Sicherstellung regulatorischer Anforderungen Optionale [...]

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[...] Weiterentwicklung zur Auditor:in bei vorhandener Auditerfahrung möglich Teilnahme an Weiterentwicklungsprojekten z. B. mit Perspektive auf Teamleitung Abgeschlossenes naturwissenschaftliches oder technisches Studium (z. B. Pharmazie, Biotechnologie, Chemie oder verwandte Fachrichtungen) Mindestens 23 Jahre Erfahrung im Bereich Qualitätssicherung insbesondere bei der Erstellung von Quality Agreements Fundierte GMP-Kenntnisse sind zwingend erforderlich Erfahrung im Umfeld steriler [. .. ] internationale Märkte und bietet seinen Mitarbeitenden ein dynamisches Umfeld mit langfristigen Perspektiven. (Junior) Qualitätsmanager (m/w/d/x) - Ready-2-Eat Lebensmittelproduktion Qualitatsmanager/in-Klinische Forschung Manager/ Quality Assurance Clinical Research (m/w/d) - in Teilzeit Qualitätsmanager (m/w/d) im Vertragsmanagement mit dem Schwerpunkt Nachtragsmanagement (Bau/ VOB) Qualitätsbeauftragte r für den Bereich im Qualitäts- und Risikomanagement Mitarbeiter Qualitäts- und Mangelmanagement (m/w/d) Fürstenwalde, Brandenburg, Germany 5 days ago Teamleiter (m/w/d) Logistik und Qualitätsmanagement Fürstenwalde, Brandenburg, [. .. ]

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Job am 13.01.2026 bei Jobleads gefunden

Staff Supplier Quality Engineer (f/d/m)

• München, Bayern [. .. ] and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a [...]

MEHR INFOS ZUM STELLENANGEBOT

[...] global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour [. .. ] Six Sigma, Problem Solving, Statistical Tools) Knowledge of EU, FDA and related regulations including QSRs, (FDA 21 CFR 820) , ISO 13485, ISO 9001 and the EU IVDD Certified internal auditor ISO 9001or ISO 13485. . Experienced in working within multi-functional, multi-regional teams Fluent in German and English languages. Good computer skills which includes Microsoft Applications, Databases and Web-based Tools. Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We [. .. ]

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Job am 21.12.2025 bei Jobleads gefunden Senior Consultant Medical Devices Quality Regulatory Affairs • Stuttgart, Baden- Württemberg Beratungs-/ Consultingtätigkeiten [. .. ] At least 7 years of professional experience in the medical device field (EU MDD and EU MDR) , gained in industry, consultancy, or a Notified Body, in [...]

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[...] quality, regulatory, or clinical roles. Solid knowledge of quality assurance and regulatory affairs within the Med Tech industry or a Notified Body environment. Qualified to perform ISO 13485 and MDSAP audits as a lead auditor. Indepth knowledge of EU Medical Device Regulations (EU MDR) and US regulations. Familiarity with medical device risk management. Handson experience in writing technical and regulatory documentation. Experience in implementing and managing medical device quality management systems (ISO 13485) . Practical knowledge of project management. Pragmatic mindset, enjoying a mix of [. .. ]

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Job am 16.12.2025 bei Jobleads gefunden (Senior) Consultant, Qualified Person • München, Bayern Beratungs-/ Consultingtätigkeiten [. .. ] Provider and Consultancy for the Development, Manufacturing and Quality Assurance of Medicinal Products. Our focus is the EU Import, Storage, Distribution and EU-Release of Investigational Medicinal Products, [...]

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[...] supporting the Clinical Trials of our Clients. For our team in Munich, we are looking for a (Senior) Consultant, Qualified Person Responsibilities Act as (deputy) Qualified Person under Granzers manufacturing authorisation Provide expertise and consulting on GMP-related items to our clients Support the import and batch release processes for client products Perform [. .. ] experience in the pharmaceutical industry with relevant experience for the position (e. g. Quality Assurance, Quality Control, Production) Excellent knowledge of GMP/ GDP regulations in Europe and US Experience as auditor Strong team work ethic and sound organizational skills for functioning with a high degree of independence on projects with minimal supervision Flexible, scientific working style and willingness for continuous education Willingness to travel (e. g. audits, meetings with clients and CDMO) Willingness to relocate to Munich Fluency in English and [. .. ]

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Job am 15.12.2025 bei Jobleads gefunden Principal Quality Engineer [. .. ] the development and implementation of quality plans that will result in short and long-term sustainable growth of the countrys specific business. Responsibilities include support to all supply [...]

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[...] chain activities, clinical team activities, marketing, commercial, GPMS, customer care, suppliers qualification, evaluation and monitoring. In addition, supports all activities related to NCs and CAPAs related to OUS activities. The Principal Quality Engineer will interact with the department staff to determine quality system requirements and provide quality support to drive the continuous assessment [. .. ] Experience with International Relations, preferred. Experience with distributors and importers, preferred. Extra Awesome Bachelors degree in engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience. ISO lead auditor certification or equivalent, preferred. 10 years of related experience in the field including: Experience leading and partnering with a quality assurance team through the various stages of development, from small startup organization to large organization. Experience supporting US and international regulatory authorities or notified bodies. Experience conducting internal audits. Why [. .. ]

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Job am 20.11.2025 bei Jobleads gefunden Senior Auditor Quality Assurance Manager (m/f/x) • Baden- Württemberg Jobticket Senior QA Auditor (m/f/d) Clinical Trials Responsibilities: Lead audits for clinical trials and medical products to ensure compliance with Gx P and regulatory standards. Develop and implement audit [...]

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[...] plans based on risk assessments and conduct internal process and vendor audits. Address and escalate serious clinical trial violations, ensuring timely resolution. Contribute to the development and maintenance [. .. ]

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Job am 23.10.2025 bei Jobleads gefunden QA Manager Medical Device Development (m/f/d) , R D Quality • Frankfurt, Hesse [. .. ] like to become part of our success story? Then join Merz Aesthetics You lead R D project teams through Design Control requirements, ensuring compliance across development phases, [...]

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[...] supporting preclinical and clinical planning, contributing to regulatory submissions, and facilitating smooth transfer to manufacturing. You manage risk and usability processes, guiding activities, documentation, and cross-functional input throughout all stages of the product development lifecycle, including maintaining the risk management plan, risk file, and usability strategies. You support audits and inspections, preparing for [. .. ] are experienced in ensuring quality compliance throughout design and manufacturing processes. You ideally hold or are pursuing certifications such as ASQ Certified Quality Manager, Certified Quality Engineer, or Certified Quality Auditor. You are proficient in both electronic Quality Management Systems (e. g. , Master Control, SAP, Oracle) and MS Office applications, supporting effective documentation and communication. You demonstrate strong organizational and communication skills, with the ability to manage priorities independently, maintain attention to detail, and clearly convey technical concepts across functions [. .. ]

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Job am 01.10.2025 bei Jobleads gefunden Regulatory Technical Reviewer (m/f/d) - Healthcare • Plattling, Bayern [. .. ] for people like you to help make it happen. Responsibilities To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with [...]

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[...] respect to product clinical performance including alignment with state-of-the-art expectations and defended risk/ benefit for the product. To formulate, maintain and improve assessment procedures and protocols in line with both CSA Group and external Authority expectations. Independently manages certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within [. .. ] UKCA, FDA) . Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures. Qualification as management system auditor in the healthcare sector. Strong interpersonal skills; self-starter; good decision-making skills and organizational skills. Technically competent to evaluate all products, including new and unique products, with assistance of other technical staff as necessary. Ability to manage multiple assessments and changing schedules and deadlines with supervision. Demonstrates technical competence [. .. ]

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Job am 15.08.2025 bei Jobleads gefunden (Senior) Quality Assurance Manager GCP (m/f/d) • Frankfurt, Hesse Work-Life-Balance [. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations including requirements for IT systems [...]

MEHR INFOS ZUM STELLENANGEBOT

[...] used in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-[. .. ] Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]

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Job am 09.11.2025 bei Neuvoo gefunden MEDICE Pharmaceuticals Pütter GmbH Co. KG Global Quality PV GCP Manager (m/w/i) • Iserlohn, North Rhine- Westphalia Flexible Arbeitszeiten [. .. ] Wir suchen eine erfahrene Fachkraft, die unsere globale Qualitätssicherung stärkt und insbesondere den Schwerpunkt GCP in unseren klinischen Entwicklungsprojekten verantwortungsvoll weiterentwickelt. In der Funktion agierst du als [...]

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[...] QS-Schnittstelle zur Clinical Research-Abteilung und unterstützt beim Sponsor Oversight. Die Aufgaben im Detail: Lead Auditor bei GCP-Audits, einschließlich Planung, Durchführung, Berichterstattung und CAPA-Nachbereitung Planung, Organisation und Begleitung interner Audits zur Bewertung von Systemen, Prozessen, Aufzeichnungen und Kontrollen in der klinischen Forschung Effektive mündliche und schriftliche Kommunikation der Auditergebnisse sowie Berichtserstellung für das Management Entwicklung und Pflege von Systemen und Tools zur Unterstützung von [. .. ]

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Job am 07.11.2025 bei Neuvoo gefunden Merz Therapeutics (Senior) Quality Assurance Manager GCP (m/f/d) , (Senior) Quality Assurance Manager GCP (m/f/d) bei Merz Therapeutics softgarden • Frankfurt, Hessen Work-Life-Balance [. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations including requirements for IT systems [...]

MEHR INFOS ZUM STELLENANGEBOT

[...] used in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-[. .. ] Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]

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