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Senior Manager of Quality Operations – Frankfurt, Germany 

 30-+-annual-leaveAnnual-performance-bonusBonus-schemeCity-locationSalary-above-industry-standard

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:

This Senior Manager of Quality Operations role is one not to be missed; it encompasses the opportunity to work with a global medical devices client. To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.

 

Apply Now!

Job Consultant

Enzo Bagmanian

Regulatory, Quality & PV

Recruitment Consultant

+44 (0) 2393 874 292

enzo@carrotpharma.co.uk

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