Quality and Regulatory Affairs Manager / Quality Management Representative (m/f/d)

We are a small medtech manufacturer with a long tradition in the field of interventional cardiology and electrophysiology equipment with offices in Heilbronn, Germany and offices and production in Sittard, the Netherlands.

For our main office in Heilbronn we are currently looking for a

Quality and Regulatory Affairs Manager / Quality Management Representative (m/f/d)

Job description:

The Q&R Manager establishes strategic goals in quality and regulatory affairs by gathering quality, research and development, business, service, and operations information; identifying and evaluating trends and options, and defining the course of action towards desired outcomes.

  • He/she improves procedures that maximize quality and regulatory standards; directing development and manufacturing of class IIb medical devices.
  • Ensures the promotion of awareness of applicable requirements throughout the company and reports to top management.
  • Provides leadership in responding to regulatory agencies (EU and worldwide) and manages international audit programs.
  • Executes control over the following systems: company policy, notifiable events, CAPA, change control, documentation control, product complaint investigation and analysis.
  • External interaction includes customer/supplier audits, quality and regulatory agreements, identifying product quality and regulatory trends; recommending corrective actions, initiating and directing local market approvals with partner or 3rd party agencies.
  • Reviews procedures of departments by recommending solutions to problems or changes in procedures.
  • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications; establishing personal networks and benchmarking of state-of-the-art practices.

Candidate Profile:

  • Education in engineering, science or QM
  • Significant experience in Quality Management Systems (Medical Devices)
  • Experience with notified bodies, audit procedures and problem solving
  • Knowledge of European regulations and standards (Medical Device Directive, Medical Device Regulation and EN ISO13485:2016)
  • Preferably knowledge of MDSAP, especially related to Australia, Brazil and USA
  • Ability to conduct internal audits and supplier audits
  • Ability to collaborate and communicate cross-culturally and cross-functionally
  • Ability to work effectively in a quickly changing, demanding environment
  • Hands-on mentality with pragmatic attitude, approachable and open-minded
  • Demonstrated leadership skills and willing to work in a small QM team
  • Business fluent German and English (spoken and written)

We offer:

  • Interesting and varied tasks in a committed and competent team
  • Permanent full-time position in an attractive working environment with flexible working arrangements
  • Overall responsibility in an international company
  • Flat hierarchies and short decision paths
  • High personal initiative and above-average commitment

Would you like to join our enthusiastic team?
We are looking forward to receiving your comprehensive application including your desired salary and your availability either via e-mail to: bewerbung@schwarzercardiotek.com or by mail to: Schwarzer Cardiotek GmbH, Human Resources, Im Zukunftspark 3, D – 74076 Heilbronn.
For any queries please do not hesitate to contact Mr. Steffen Würz, +49 7131 / 2774 500.

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