Quality System Engineer

Jobangebot - BIOTRONIK SE & Co. KG

Connecticum Job-Nr. 1445127 / 33922
  • Arbeitgeber: BIOTRONIK SE & Co. KG
    Beschäftigungsart: Professionals Job
    Jobdatum: 13. Oktober 2021
    Fachbereiche: Ingenieurwissenschaften: Qualitätssicherung
    Einsatzort: Singapur; Asien

    Quality System Engineer - Jobangebot

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    Quality System Engineer

    As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

    The Quality System Engineer is responsible for Quality Management Systems (QMS) implementation and maintenance, in the areas of Supplier Quality Management. He/she shall also assist the Lead Quality System Engineer/Director of Quality management in the successful planning and implementation of Management Review, CAPA and Quality Audits (both internal and external).

    Your Responsibilities

    • Ensure the compliance of QMS towards applicable medical devices regulations
    • Assist Lead Quality System Engineer to perform Monthly Quality Data Analysis as input for the Site Quality Management Review
    • Serve as the organizational focal point for Supplier Management matters, including supplier qualification, supplier audits, supplier continual assessments, supplier change management, and supplier nonconformance management
    • Responsible to drive improvement in supplier management processes, including policy, procedures, KPI metrics and reporting tools as required to fulfil applicable standards and regulations
    • Support stakeholders in supplier development effort to ensure compliance to procedures and specifications when required
    • CAPA Coordination and facilitator of the site CAPA Review Board meetings
    • Assist Lead Quality System Engineer/Quality Director in planning and execution of both internal audits and external audits
    • Assist Lead Quality System Engineer in conducting quality awareness training, including new hire orientation
    • Create, update and develop the training material for QMS
    • Assist Lead Quality System Engineer on QMS improvement initiatives as required

    Your Profile

    • Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences)
    • Two to five years’ work experience in a quality function in regulated environment (medical devices/pharmaceutical industry)
    • Know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, MDD, AIMD, applicable local regulations.
    • ISO 13485 auditor Certification
    • Experience as lead/auditee in third party audits (FDA, Notified Bodies, Competent Authorities) is preferred
    • Desktop applications, analytical tools, presentations, document management.
    • Documents and Quality Records lifecycle management
    • Good communication skills with people from all levels in the organization
    • English(spoken and written), German is a plus (In order to liaise with German/local speaking external suppliers' queries)
    • SAP and Success Factor User experience is a plus

    What we offer

    • being encouraged to think and act entrepreneurially
    • working in global teams and projects
    • developing yourself professionally

    Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

    Location: Singapore| Working hours: Full-time

    Apply now under: www.biotronik.com/careers

    Job ID: 33922 | Contact: Human Resources

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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Quality System Engineer

Jobkennzeichen Connecticum Job-Nr. 1445127 / 33922
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Arbeitgeber-Profil: BIOTRONIK

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