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Auditor internal • teningen

Zuletzt aktualisiert: vor 6 Tagen
Global Corporate Auditor (gn)

Global Corporate Auditor (gn)

IntuitiveFreiburg im Breisgau, BW, DE
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
  • Gesponsert
Referent •in Arbeitssicherheit (w / m / d)

Referent •in Arbeitssicherheit (w / m / d)

Abfallwirtschaft und Stadtreinigung FreiburgGmbHfreiburg im breisgau, baden-württemberg, Germany
Die ASF steht in Freiburg für Stadtsauberkeit,Abfallentsorgung und zuverlässigen Kundendienst.Rund 500Beschäftigte sorgen täglich für Bürgerservice auf hohem Niveau. Unsere Schwerpunkte : Abfallsamml...Mehr anzeigenZuletzt aktualisiert: vor 6 Tagen
Automotive System Engineer - (m / f / d)

Automotive System Engineer - (m / f / d)

Technology & StrategyBaden-WürttembergGermany, Bade-Wurtemberg
We are looking for a new engineer with experience related to Automotive System Engineering (M / F / O), to assume the following responsibilities : . Responsible for an end customer system function and si...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Accounting Assistant Mini-Job (m / w / d)

Accounting Assistant Mini-Job (m / w / d)

PhaseformFreiburg im Breisgau, Baden-Württemberg, Germany
Quick Apply
Are you a numbers whiz who loves keeping things organized behind the scenes? Phaseform is a pioneering European deep-tech startup that has recently been awarded the highly acclaimed EIC Accelerator...Mehr anzeigenZuletzt aktualisiert: vor 26 Tagen
Quality Assurance GCP Manager (m / w / d)

Quality Assurance GCP Manager (m / w / d)

Dr. Falk Pharma GmbHFreiburg, de
As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastroin...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Job in Germany : Employee for IT support of the laboratory infrastructure (m / f / d)

Job in Germany : Employee for IT support of the laboratory infrastructure (m / f / d)

Universitätsklinikum FreiburgFreiburg im Breisgau
Blood tells us more than 1000 words.The Institute of Clinical Chemistry is looking to recruit a.Employee for IT support of the laboratory infrastructure (m / f / d). The Institute of Clinical Chemistry ...Mehr anzeigenZuletzt aktualisiert: vor 26 Tagen
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Customer Support Engineer & PL (f / m / d) in Budapest

Customer Support Engineer & PL (f / m / d) in Budapest

Cinemo GmbHBudapest, Baden-Württemberg, Germany
Understanding of software engineering processes with complex technical issues.Significant experience in a similar role.Experience in managing small-scale projects. Very good knowledge of C and C++ p...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Global Corporate Auditor (gn)

Global Corporate Auditor (gn)

Intuitive SurgicalFreiburg im Breisgau, BW, Germany
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Mehr anzeigenZuletzt aktualisiert: vor 6 Tagen
Quality Engineer - QM System Employee (m / f / d)

Quality Engineer - QM System Employee (m / f / d)

TDK-Micronas GmbHFreiburg im Breisgau
Vollzeit
As a quality engineer - QM system employee (m / f / d), you will support the development and implementation of quality assurance measures in existing production processes. You will be involved in custom...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Referent •in Arbeitssicherheit (w / m / d)

Referent •in Arbeitssicherheit (w / m / d)

Abfallwirtschaft und Stadtreinigung Freiburg GmbHFreiburg im Breisgau, Germany
Die ASF steht in Freiburg für Stadtsauberkeit, Abfallentsorgung und zuverlässigen Kundendienst.Rund 500 Beschäftigte sorgen täglich für Bürgerservice auf hohem Niveau. Unsere Schwerpunkte : Abfallsam...Mehr anzeigenZuletzt aktualisiert: vor 18 Tagen
Global Autoimmunity Medical Director (m / f / d)

Global Autoimmunity Medical Director (m / f / d)

Thermo Fisher ScientificFreiburg, Germany
Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasin...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Night Auditor in TZ (all genders)

Night Auditor in TZ (all genders)

IntercityHotel FreiburgFreiburg Breisgau, Deutschland
IntercityHotel steht für Mobilität, Komfort und Service.Sie sind mehr als nur ein praktischer Aufenthaltsort für Reisende : In unseren IntercityHotels laden wir Gäste dazu ein, sich zu entspannen un...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
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Expert : in Internal Audit (m / w / d)

Expert : in Internal Audit (m / w / d)

JobRad Leasing GmbHFreiburg im Breisgau, Germany
135,00 € stündlich
Wir haben das Rad nicht neu erfunden – aber das Dienstrad!.JobRad® ist Markt- und Qualitätsführerin der boomenden Radleasing-Branche. An unserem Hauptsitz in Freiburg und in unserem Außendienst in g...Mehr anzeigenZuletzt aktualisiert: vor 6 Tagen
Prüfer ­­ / ­­ Prüfungsgruppenleiter ­­ / ­­ Prüfungsleiter

Prüfer ­­ / ­­ Prüfungsgruppenleiter ­­ / ­­ Prüfungsleiter

vbw Verband baden-württembergischer Wohnungs- und Immobilienunternehmen e.V.Baden-Württemberg, DE
Wir sind der genossenschaftliche Prüfungs- und Interessenverband der rund 300 Wohnungs- und Immobilien­unternehmen in Baden-Württemberg, mit Sitz in Stuttgart. Zur Unterstützung und Erweiterung unse...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Software Team Lead / Project Manager (Medical Device)

Software Team Lead / Project Manager (Medical Device)

Dr. Langer Medical GmbHWaldkirch, Baden-Württemberg, Germany
As a Software Team Lead / Project Manager in the R&D department, you will be part of an interdisciplinary and highly skilled team. You will be responsible to lead a team of software developers f...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
Process & Project Manager ATEX / IECEx - Quality Management (w / m / d)

Process & Project Manager ATEX / IECEx - Quality Management (w / m / d)

SICK AGWaldkirch, DE
Harmonisieren Sie die Qualitätsmanagement-Prozesse im gesamten SICK-Konzern und koordinieren Sie die entsprechenden Roll-outs. Übernehmen Sie die zentrale Betreuung von konzernweiten Qualitätsmethod...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Compliance Auditor internes Quality und Risk Monitoring (w / m / d)

Compliance Auditor internes Quality und Risk Monitoring (w / m / d)

KPMGFreiburg, DE
Compliance Auditor internes Quality und Risk Monitoring (w / m / d).Karrierelevel : Berufserfahrene.Anstellungsart : Festanstellung in Vollzeit oder Vollzeitnah. Begleite KPMG bei den zukünftigen Herausfo...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Techniker / Ingenieur Qualitätssicherung (m / w / d)

Techniker / Ingenieur Qualitätssicherung (m / w / d)

BertrandtFreiburg im Breisgau
Sie sind für die systematische Erfassung, Überwachung und Analyse von Qualitätsproblemen zuständig.Sie planen und koordinieren Optimierungsmaßnahmen und setzen diese zu nachhaltigen Lösungen um.Sie...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Configuration Manager for Ground Segment [24075]

Configuration Manager for Ground Segment [24075]

CS GROUPBW, de
As part of the Airbus team, you will have the following responsibilities : .Ensuring a coherent product configuration (requirements, development, production) throughout the entire life cycle of the p...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Manager für Umweltmanagement und Arbeitssicherheit (ESH) (m / w / d) - REF69649X

Manager für Umweltmanagement und Arbeitssicherheit (ESH) (m / w / d) - REF69649X

ContinentalHerbolzheim, BW, DE
Leitung und Koordinierung aller ESH Environment, Safety, Health und Security AktivitätenVerantwortung und Sicherstellung der Erreichung von ESH-Vorgaben im Sinne der internen und externen Stakehold...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Global Corporate Auditor (gn)

Global Corporate Auditor (gn)

IntuitiveFreiburg im Breisgau, BW, DE
Vor 7 Tagen
Stellenbeschreibung

Company Description

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Job Description

Primary Function of Position

The Global Corporate Auditor will support the execution of an efficient and effective Quality audit program. They will support the internal, external, supplier and clinical audit programs to ensure compliance to the applicable regulatory requirements and standards. This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the company's risks appropriately. They will use Quality Auditing principles, tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings, by working with cross functional and varying level of departments / business partners to ensure comprehension, development, and execution of corrective / preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems, processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for long-term strategic QMS improvement.

Roles and Responsibilities :

  • Conduct internal audits across all global sites.
  • May also coordinate internal audits and provide oversight to external contractors.
  • Support supplier and clinical audits as assigned.
  • Support external audits or regulatory inspections across global sites
  • Complete gap assessment for regulations, regulatory standards, and corporate procedures
  • Train company employees on Quality System Regulations and quality system foundational principles
  • Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
  • Support Quality System projects for new and changing regulatory requirements Serves as the lead coach / consultant to educate internal customers on regulatory compliance processes and regulations
  • Create, approve, and maintain company quality documents, such as quality procedures, work instructions, and forms
  • Support CAPA program as audit findings are an input to the CAPA process.
  • Review, approve, provide feedback on CAPA documentation as assigned
  • Analyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support quality improvement projects.
  • Prepare responses to regulatory audit observations.
  • Ensure that responses are clear, comprehensive, accurate, and well written to mitigate potential for further regulatory actions.
  • Provide data to support; Risk based audit schedule, process analysis, process controls, FDA trending and finding history, and needed process improvements activities
  • Support implementation and continuous improvement of the audit programs, auditor qualification programs, and company-wide inspection readiness.
  • Support, consult, train, and lead quality improvement projects
  • Provide Quality System Consultation Support new site integration activities across global sites
  • Assist in the development and reporting of Quality System Metrics and KPIs

Qualifications

Required Knowledge, Skills, and Experience :

  • ISO certified lead auditor (ISO 9001, ISO 13485 and / or ISO 14155 or ASQ CQA)
  • Minimum 2+ years of FDA / ISO 13485 lead auditing experience
  • Minimum 5 years of experience in quality in the medical device industry
  • Previous experience conducting internal audit is must
  • Experience conducting supplier and clinical site audit is a plus
  • Quality Engineer, Software Quality and Validation experience is a plus
  • Strong knowledge of EU-MDR, ISO 13485 : 2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, , Health Canada, and other international regulatory requirements
  • Previous experience participating in notified body and FDA inspections
  • Familiarity with GMPs related to Combination and Drug Products
  • Ability to work on virtual teams, remote management; self-directed
  • Ability to be a team player and a partner to the cross- functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
  • Critical thinking skills and a passion to work in a fast-paced industry with complex / cutting edge technology
  • Strong organizational, written and verbal communication skills, remote working apps and the proven ability to prioritize tasks effectively in a deadline-driven environment
  • Required Education and Training

  • Minimum Bachelor of Science degree in Technical, Engineering or Science related field.
  • Additional Information

    Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerberinnen und Bewerber gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung.