Senior Manager of Quality Operations – Frankfurt, Germany – Innovative Medical Device Company – Negotiable Salary, Bonus Scheme and 30 days holidays

The Company:

• An innovative IVD Medical Device company looking to expand their team
• Working across multiple projects
• Excellent career progression opportunities
• Great training and development
• Possible promotion within 2-3 years and lots to learn.

The role:

• Contributes to the quality control of IVD products following ISO 13485, ISO 9001, IVDR GMP standards, and applicable national laws and requirements.
• Analyses complaints and determines the investigation approach as defined by Standard Operating Procedures.
• Monitors tasks for the timeline and reviews data for completeness.
• Coordinates paperwork and other documentation generated by investigation and addresses concerns.
• Supports customer communication.
• Supervises serological work for IMD products.
• Maintains departmental SOPs
• Monitors department metrics and trends.
• Trains employees as needed.
• Works with Technical Support Supervisor/Manager for timely complaint testing.
• Conducts Design History Review and product release.
• Supports internal and external audits.
• Evaluate release testing against the requirements.
• Coordinates sample submissions.
• Supports contract-manufacturer interaction.
• Responsible for internal IVDR studies.

You:

• A bachelor's degree in chemistry, biology or another scientific discipline.
• A minimum of 5 years experience in Quality Assurance in an IVD/medical device atmosphere.
• Strong background and knowledge of ISO standards (9001, 13485, and IVDR standards) with the ability to apply them successfully.
• Leadership experience.
• Fluency in both English and German – German must be at a C1 level.
• Self-motivator.
• High interest in the technical topics of the industry and eagerness to learn more.
• Ability to provide technical expertise to team members in supporting compliance matters.

What you should do next:

Offering a very competitive base salary and benefits package, if you are interested in learning more, please contact me directly today as we are looking to appoint you as soon as possible. For further information please contact me at Enzo@carrotpharma.co.uk or +44 (0) 2393 874 292.