What does this position offer to you?

● Competitive remuneration package - €60K - €70K

● Work for the top company in their field

● Fast-paced, intellectually intense, service-oriented environment

● Innovative projects with the latest modern tech-stack

● Diverse trainings and possibilities to grow and expand your skills

● Location based in Hamburg

What will be your tasks?

● Responsible for verifying Design transfer activities to ensure compliance to internal procedure and regulatory needs

● Monthly and Quarterly Reporting which include but not limited to data of CAPA, Change Control, NCR, Process Capability, Scrap, Training, USFDA readiness, ISO 13485:2016 implementation, plant hygiene control Maintaining the document distribution and change logs

● Developing the annual audit plan & training internal auditors

● Responsible for team management which includes but not limited to training of team member, support team member, their performance evaluation, problem solving Participating in Root Cause Analysis (RCA) & improvement projects

● Document and Change control

● Training employees on Good Manufacturing Practices (GMP)

● Provide quality guidance and participation in conducting risk management activities

● Develop quality assurance specifications, test methods, sampling plans and related written procedures

Who you are: You…

● Prior quality engineering experience in the medical device.

● 3+ years of relevant industry experience focused on Medical Device / Auditing /

● Knowledge of Quality System Standards/Regulations (ISO 13485, 21CFR Part 820, MDD93/42/EEC, ISO 14971, GMP

● Fluent written and spoken German and English

● Experience in the use of statistical tools (SPC, Six Sigma, MiniTab etc.).

● Support in Validations activities including equipment qualifications, master validation plans

Do you want to know more?

Once you have applied with your CV (no letter of motivation is needed), we will be discussing all your interests and needs in detail. We will also contact the client in your behalf, introduce you to him / her and make sure that you are prepared very well for the upcoming interviews.

If the above-mentioned position doesn't match your needs, then I would suggest to contact me directly for what I have available.

Contact Details:

● E-Mail: p.cioran@sciproglobal.de

● Tel: 089 / 21 09 39 79

● Xing: https://www.xing.com/profile/Patricia_Cioran2/cv?sc_o=mxb_p

● LinkedIn: https://www.linkedin.com/in/patricia-cioran-8a4a0549/