Manager Quality & Regulatory Affairs

At MK-dent, we're solving today's most important problems in dentistry with talented individuals who embrace our passion to change the world. Our obsession with building better dental products empowers thousands of dentists and helps millions of patients suffering from oral diseases worldwide. From our testing labs to our quality management team, we are looking for the next generation of employees to join us in our commitment to improving lives.

Ihre Aufgaben

Upon signing of the contract you will be given all the details and sufficient time to make your decision. We want you to make the right one for you career.

• Step 4 - Onboarding Our most important goal here is to make you feel welcome. Connecting with your colleagues and experiencing craftmanship in the first week will give you a head start at MK-dent.,

• Manage individual project priorities, deadlines and deliverables as well as external consultants.

• Create and test SOPs according to GMP, MDR & ISO 13485:2016.

• Monitor the CE conformity process according to MDD & MDR.

• Prepare and execute internal and external audits.

• Plan and conduct trainings.

• Participate in product development projects.

Ihr Profil

• BS degree in engineering, life sciences or similar technical field of study or equivalent practical experience.

• At least 2 years of experience in quality management or regulatory affairs in the medical industry or a similar environment.

• Excellent team player with extensive communication and problem-solving skills.

• Working proficiency and communication skills in verbal and written English and German.,

• Master's, PhD degree, further education or experience in engineering, computer science or other technical related field.

• Experience with one or more applications including but not limited to: PLATO SCIO, Q-DAS qs-STAT, Q-DAS solara.MP.

• Understanding of GMP, MDR & ISO 13485:2016 principles and requirements.

• Interest and ability to learn as needed.

Kontakt

Recruitment Marie-Curie-Straße 2 22941 Bargteheide

E-Mail: jobs@mk-dent.com