Permanent

Teamleiter Quality (m/w/d) - RAUM Tuttlingen

  • LocationTuttlingen, Baden-Württemberg, Germany
  • Salary€120000 per annum
  • SectorCompliance
  • Job RefBH-87584
  • ContactNici Herz
  • Published3 days ago
Nici Herz

Nici Herz

Lead Consultant

Übersicht

Ein international agierendes Unternehmen, welches Chirurgie Produkte herstellt,sucht nachVerstärkung im Führungsbereich Quality.

Gehalt: 85 000 € bis 120 000 €      (je nach Qualifikation)                                                                                  
Vertragsform: Unbefristete Festanstellung                                                                       


Aufgaben
  • Übernehmen Sie die Führung eines Teams im Bereich Qualitätsmanagement 
  • Führung, Motivation und Förderung der Mitarbeitenden 
  • Verantwortlich für die strategische Gestaltung und Weiterentwicklung der Prozesse im Bereich Vigilanz 
  • Sicherstellen und Überwachen der Prozesse zur Bewertung und Meldung von schwerwiegenden Vorkommnissen an zuständige Behörden und benannte Stellen.
  • Nachhaltige Optimierung von Prozessen, Strukturen und Organisation innerhalb des Verantwortungsbereichs
  • Aktive Mitarbeit in lokalen und internationalen Projekten zur Optimierung der QM-Prozesse


Profil
  • Abgeschlossenes Studium in Ingenieurwesen, Naturwissenschaften, Medizintechnik
  • Know How im Bereich Vigilance
  • Mehrjährige Berufserfahrung Medizintechnik 
  • Kommunikationsstärke in Deutsch und Englisch
  • Fundierte Kenntnisse in nationalen und internationalen regulatorischen Anforderungen an Medizinprodukte (z.B. MDR, CFR)
  • Führungspersönlichkeit, die Mitarbeiter*innen und sich selbst weiterentwickelt und Teamgeist fördert.
  • Lösungsorientiertheit, strukturierte und verantwortungsbewusste Arbeitsweise, analytisches Denken

Wir bieten 
  • Spannende innovative Projekte
  • Großes Unternehmen mit Herz für jeden einzelnen Mitarbeiter
  • Breites Produktportfolio
  • Flache Hierarchien und viel Flexibilität
  • Zahlreiche Mitarbeiterleistungen 
  • Kinderfreundliches Unternehmen
  • Weiterbildungsmöglichkeiten


Besuche unsere Website und unser LinkedIn-Profil für weitere Stellenangebote.

Wir respektieren Deine persönlichen Daten und würden sie niemals an Dritte weitergeben! Für weitere Informationen darüber, wie wir Deine Daten handhaben, kannst Du gerne unsere Datenschutzerklärung auf der Austin Fraser-Website überprüfen oder uns unter privacy@austinfraser.com kontaktieren.

Austin Fraser GmbH, Lenbachplatz 1, 80333 München Geschäftsführer: Peter Hart Handelsregister: HRB 200249 Sitz der Gesellschaft München
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    Supplier Quality Assurance Team Lead

    UK

    Austin Vita are delighted to be offering a fantastic opportunity for a talented and experienced Supplier Quality Team Lead to join an innovative Medical Device company who design and manufacture at their site in London. You will play a pivotal part in implemeneting and constantly striving to improve plans and processes with Supplier Quality, whilst mentoring and leading members of the Team.

    Benefits include:

    • 25 days annual leave, plus bank holidays
    • Compressed 4 day week & blended working options
    • Enhanced pension scheme (with salary sacrifice option)
    • Bonus schemes
    • Sharesave scheme
    • Healthcare cash plan
    • Life assurance
    Responsibilities:
    • Manage and provide leadership to the Supplier Quality Assurance Team.
    • Developing, implementing, maintaining and supporting the promotion of the Quality Assurance strategy
    • Maintaining the Companies Quality Management System and ensuring compliance to all applicable regulations and standards
    • Ensuring compliance with ISO 13485, Medical Device Single Audit Program (MDSAP), and other regulations under which the Companies sell their products
    • Supporting Continued Improvement activities and initiatives across the Company using best practices such as Lean Six Sigma and Lean Manufacturing.
    • Ensure that supplier quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR)
    • Report on the effectiveness of the supplier quality processes within the Business Management System and any needs for improvement
    • Reporting on the supplier quality performance of the QMS
    • Planning and preparation of supplier audits.
    • Manage with input from other business functions, supplier selection, approval and ongoing Supplier evaluation process. Support internal projects by providing guidance on supplier evaluation and other supplier related activities.
    • Responsible for the Management of supplier concessions and Supplier Corrective Action Report (SCARs);
    • Periodic review of supplier certification and documentation;
    • Manage, with input from other key stakeholders and work streams, the Supplier Quality performance Score Card analysis
    • Provide input to Supplier Quality performance for Management Review and other Top Management reviews
    • Participate in the CAPA process
    • Perform supplier audits.
    Experience required:
    • Previous experience in a Supplier Quality/Quality Management or Supplier Quality/Quality Lead role
    • Direct interaction with Regulatory authorities;
    • Expert knowledge in ISO 13485 and MDASP requirements preferred
    • Expert knowledge in Continuous improvement activities and problem solving techniques.
    • ISO 13485 Lead Auditor desirable
    For immediate consideration please forward your most up to date CV

    Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

    Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

    Check us out on our website and LinkedIn for more roles.

    We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

    Senior Quality Engineer - R&D

    UK

    Our client, a global medical device manufacturer, have a fantastic opportunity for a talented and experienced Senior R&D Quality Engineer to join the R&D QA Team based in Hampshire. You will play a pivotal part in concept research control and design control activities for NPI, including; product & process development , design reviews, design change, DHF lifecycle management and areas of risk management.

    Benefits include:

    • Pension scheme
    • 25 Days annual leave (plus bank holidays)
    • Life Assurance
    • Healthcare
    • Hybrid working
    Responsibilities:
    • Ensuring compliance to global Design Control and Risk Management procedures adhering to ISO 13485, ISO 14971, MDSAP and MDD/ MDR.
    • Develop and/or review of clinical trial sample/product/process development documentation, test method validation documentation, software/computer system validation documentation and process validation documentation.
    • Support R&D in the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the design development process.
    • Provide support to maintain Quality System Regulation requirements including internal and external audits of Quality System.
    • Support company goals and objectives, quality system processes such as CAPA system, Change Control, Non-Conformance, KPIs, Management Review, Adverse Clinical Events or Customer Complaints, and Internal Audits.
    • Create a culture of quality awareness, teamwork, and cooperation with all groups within the facility and as part of global cross functional teams.
    • Work closely with Regulatory Affairs and Research and Development functional groups, to ensure compliance to applicable standards (external and internal) such as ISO, FDA-QSR and GMP.
    • Participate in Regulatory Agency Inspections of the facilities and ensures corrective actions are performed as necessary.
    • Support Manufacturing in Validation and Control Planning.
    Experience required:
    • Extensive related experience in the medical device field, Invitro Diagnostic’s or pharma would be preferable
    • Bachelor in an engineering or science discipline
    • Practical application of ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820. MDSAP & MDD/ MDR is ideal.
    • Good Manufacturing Practice (GMP) experience is ideal. Good Laboratory Practice (GLP), or Good Clinical Practice (GCP) is a bonus.
    • Applied technical knowledge of Qualitative and Quantitative data analysis and statistical tools is ideal.
    • Six Sigma Green Belt qualified or CQE is a bonus.
    • Project Management qualified is a bonus.
    For immediate consideration please forward your most up to date CV

    Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

    Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

    Check us out on our website and LinkedIn for more roles.

    We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU