Quality Manager

  • Location

    berlin, Germany

  • Sector:

    Quality

  • Salary:

    60000

  • Contact:

    Luke Fines

  • Job ref:

    21863

Quality Manager:

Our client is presently looking for a qualified professional in the position of Quality Manager who would be thrilled to join their Quality Unit team based at their company headquarter in central Berlin. This is an incredible opportunity for somebody who is motivated, goal oriented, structured & passionate to make a positive impact in an incredibly interesting company. The role will report directly to the VP Q&R, Risk and Safety.

Our client is utilising nanotechnology, a software medical device and hardware (all CE certified) for life-saving treatments in tumour therapy. These products are Class IIb – III and ongoing projects include 2 new devices in development, MDR transition and FDA approvals. There are nine devices in total to work with that support patients in hospitals and clinics, and the products have impressive clinical data in treating cancer.

 

Tasks:

• Assist the QMR in the creation and upkeep of the QMS.

• Assist with the digitalization of the QMS (non-paper-based document management and training management system) by ensuring that EN ISO 13485 and MDR 2017/745 criteria are met.

• Assist the RA and Product Management teams in developing Device Technical Files that meet all applicable criteria.

• Liaising with the notified body and regulatory authorities to organise audit activities.

• Assist in the integration and consolidation of quality management processes.

• Lead and moderate NCR and CAPA committee meetings to resolve deviations and issues raised from both internal and external sources.

• Ensure the stability and robustness of the QMS by handling and coordinating changes originating from the change control process.

• Identify gaps, loops, and opportunities for improvement by mapping QMS processes.

• Support process owners in implementing lean QMS processes by driving continuous improvement initiatives for existing QMS operations.

• Support the Risk Manager and PRRC Vigilance in EN ISO 14971 compliance efforts by maintaining the PFMEA risk registry.

• Lead computer system validation activities and support the validation activities at their Berlin site. Also, responsible to lead the QA-Validation Engineer.

• Be the driving force behind supply chain improvement initiatives.

• Provide basic QM training to new workers as part of their onboarding process.

 

Requirements:

• Working in a Quality and Regulatory function within a medical device company for at least 3-5 years is required.

• It's ideal if you have prior experience working with active medical devices.

• Working knowledge of the following standards is required: DIN EN ISO 13485:2016, MDR 2017/745, EN 14971:2020, and EN 60601. Knowledge of 21 CFR Part 820 and MDSAP is a plus.

• Work experience with Microsoft Office 365 package tools is required.

• Understanding of CAPA resolution using the 8-D approach and a variety of root cause analysis techniques.

• Understanding of process mapping (preferably using Microsoft Visio) and areas for improvement.

• Kaizen knowledge is a bonus, as is knowledge of Lean Six Sigma.

• Excellent written and vocal knowledge of the German and English languages (minimum C1/C2).

For more information or to apply, please contact Luke Fines:

Email: luke.fines@adaptivelifescience.com
Phone: +442045492962