Quality Systems Specialist

vor 3 Wochen

Rastatt, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Our partner is a leading company in the medical technology industry that offers innovative solutions for healthcare. With a focus on quality and safety, the company develops and manufactures products that are used in hospitals and healthcare facilities worldwide. We are looking for a Quality System Engineer to support our partner.

Key Responsibilities

  • You will continuously maintain and develop the Quality Management System (QMS), including creating, reviewing and updating procedural and work instructions and associated forms.
  • You will advise and coach process owners in the creation of standard operating procedures (SOPs) and ensure QMS compliance.
  • You will train and instruct employees on compliance and quality-related topics to ensure a high level of quality awareness throughout the company.
  • You will process deviations in the quality system, including analyzing and rectifying CAPA and NC processes.
  • You will investigate the causes of deviations and define and implement suitable corrective measures.
  • You will plan, conduct and coordinate internal audits to ensure compliance with quality standards.
  • You will support external audits, such as third-party audits, FDA inspections and DEKRA audits, as well as management reviews.

Requirements

  • You have successfully completed an engineering degree in medical technology, plastics technology, mechanical engineering or a comparable qualification.
  • You have several years of professional experience in the field of medical technology and sound knowledge of quality management.
  • You are familiar with the quality management standards for medical devices, such as ISO 13485, 21 CFR 820, as well as risk management in accordance with ISO 14971 and GMP for medical devices.
  • Knowledge of the Medical Devices Act (MPG) and statistical knowledge are an advantage.
  • You are characterized by excellent presentation and moderation skills and have a strong sense of project management as well as time and self-management.
  • You have a very good command of written and spoken German and English.

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