Quality Assurance Regulatory Affairs Manager - Breckerfeld, Deutschland - EPM Scientific

Beschreibung

M/F/D

As QARA Manager you will ensure that the quality management system and products comply with all local, national and international standards and legal/regulatory regulations as well as customer requirements.

• Advise on long-term quality assurance requirements and contribute to proposing a strategy in line with functional management.
• Oversee quality assurance activities to ensure proper production results through effective quality controls and validated processes and software.
• Control and audit your own systems and those of external suppliers to ensure product quality and compliance and to initiate and/or implement improvements.
• Lead the management of non-compliance, corrective and preventive actions, complaint handling, risk management and post-market regulatory activities and ensure that these are properly implemented.
• Ensure that all quality, safety and environmental system procedures are kept up to date and regularly reviewed by the right people.
• Lead the implementation, maintenance and improvement of quality systems based on information in the organization's strategic plan, audits, standards, regulatory changes and the priorities within the organization.
• Ensure the proper preparation and success of internal and external (system and product) audits of authorities and stay informed of future changes.
• Ensure that the quality assurance system, legal requirements and GQM aspects are understood and applied throughout the organization at all levels by affected employees by carrying out appropriate training.

Responsibilities

• You have completed a degree in engineering, chemistry, or an equivalent scientific qualification. A degree in business administration/management/business optimizes your profile.
• You have several years of experience in the area of ​​quality management in a medical technology manufacturing company or a pharmaceutical company.
• You have a thorough knowledge of ISO standards (13485, 9001, Qualification as a lead auditor ISO 13485 is an advantage.
• You have practical knowledge of the EU Medical Devices Regulation (MDD) and the Medical Devices Directive (MDR). Knowledge of FDA requirements preferred.
• You have mastered several approaches and methods for continuous improvement (e.g. FMEA, Kaizen methodology, VSM, Lean Manufacturing, 5S).
• You have a results and quality oriented approach, your focus is always on the customer, you are an analytical thinker, you have good communication skills and you are a very dedicated person.
• You speak and write English and German fluently. Knowledge of other European languages ​​will be an advantage.