Quality Systems Engineer

Job content

We are currently recruiting for a Quality Systems Engineer at our site in Nuremberg, who will be responsible for supporting the day-to-day business of the quality management system, and the implementation of MDR.

The role covers our Nuremberg, Neustadt and Czech Republic sites, and will focus on providing support to other departments in relation to change control and document control. It will also be responsible for dealing with external requests from all external authorities, providing theme with the relevant information for any audits, and supporting other departments to ensure they also provide the correct information.

This is a great opportunity for someone who thrives in a varied role, who has a strong quality background, and knowledge of quality with a medical device or pharma industry.

What will this role involve?

• Support and independent implementation of sub-projects for the administration of the QM system including the implementation of the new European Medical Device Regulation
• Support of processes outsourced to the AMS Group
• Support of AMS Group Regulatory Affairs with the product registration of Resorba medical devices, especially within the scope of the MDR but also worldwide
• Independent data collection and analysis, e. g. for approval purposes
• Participation in and support of internal, cross-group and external audits and inspections.
• Support in answering questions from notified bodies, domestic and foreign authorities, etc.
• Participation in ORACLE data management in cooperation with AMS Group IT
• Support in the development of new products for quality-related issues
• Participation in the important QM system processes Non Conformity, CAPA, Change Control, etc.
• Assistance to relevant stakeholders on compliance issues; including the implementation of GxP in accordance with regulatory requirements and continuous improvement.
• Training of employees in quality issues
• Performing other duties assigned by the employer.

What we’re looking for?

• Required degree in engineering, science, microbiology, chemistry or related fields or equivalent
• Relevant experience in the medical device sector, in the pharmaceutical or GxP sector, preferably in a QA role or alternatively in a regulatory role.
• Broad experience in QMS or approval.
• Experience in the medical device industry preferred.
• You know exactly the applicable regulations for quality management systems and the ISO quality requirements.
• Excellent knowledge of German and English (spoken and written)
• Strong self-motivation, well structured and organized, extremely independent, positive “can do” character
• High level of responsibility, reliability, independence and communication skills
• Team player
• You have excellent negotiation skills
• You can supervise several projects at the same time

Who are Advanced Medical Solutions?

When we say we’re a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we’re not joking. But we’re much more than that...

With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We’re highly dependent on the creativity of our employees for our future growth and success. Our motto ’Care, Fair, Dare’ summarises our culture, and defines the principles of how we operate as one team to achieve success.

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Job Types: Full-time, Permanent

Work Remotely:

• No