Quality Engineer (m/f/d) Medical Technology Products & Systems

JOB SOURCE: HEADHUNTER
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  • Worldwide operating medical technology company
  • Challenging quality engineer position in a renewed organization structure

Firmenprofil

As part of the Quality & Regulatory (Q&R) organization within the client, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

Aufgabengebiet

  • Ensure that appropriate quality plans are made and a suitable quality system is in place, for both New Product Introductions (NPI's) as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System (QS) design.
  • Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems.
  • Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.).
  • Review calibration plans and records, environmental controls, and training plans and records.
  • Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.
  • Approve which processes need validation/re-validation after changes, and verify processes and plans/records.
  • Accountable for ensuring Manufacturing quality systems are established, maintained and documented according to needs of the business, customers and applicable quality system standards ®ulations.
  • Provide oversight of Q&R Manufacturing NPI projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level.
  • Support problem investigations and effective Corrective and Preventive Action actions and programs.

Anforderungsprofil

Essential
  • Engineering degree in a Technical discipline or equivalent professional qualification and experience
  • 5+ years industrial experience
  • Working experience with mastered regulatory compliance awareness, including at a minimum ISO 13485 and US CFR 820
  • Demonstrated effectiveness in independently investigating problems and moving them towards resolution
  • Organized/structured work approach
  • Strong English and German communications skills, written and oral
  • High reliability and quality focus
  • High engagement, motivation and flexibility
Preferred
  • Education/Experience in the quality, compliance or regulatory area, preferably in a healthcare environment
  • Experience in a regulated industry environment
  • Knowledge of quality tools/techniques and analysis methods
  • Experience in an international environment

Verg├╝tungspaket

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of the division, you will be responsible for successfully dealing with and managing relationships with approval agencies such as the US Federal Drug Administration (FDA). A person who is excited by new challenges, has strong technical competencies, and demonstrates resilience is most likely to succeed in these challenging, often demanding situations. However, by taking pride in all you do and inspiring others around you to prioritize Quality above all else, you'll be contributing to a higher Quality of life for billions and helping the company deliver innovation that matters.

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