Senior Quality Systems Manager and Notified Body Accountant

Location: Germany

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Hessen Germany.

Global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.

ROLE DESCRIPTION

- Responsible for QM-Systems of Quality Management Medical Devices Division including conception, design and implementation of harmonized
processes for Quality Assurance and Quality Management
- Responsible divisional Key Contact for Corporate Notified Body regarding ISO 13485 and MDD certification including creation of divisional change
notifications and review of local change notifications
- Responsible for divisional audit planning including of follow up of divisional audits and management of audit system
- Global Internal Audits according to ISO 9001, ISO 13485, MDD and 21 CFR 820 of FK organizations. Ensure that quality requirements are implemented
and being followed, and approve corrective action plans and approaches
- Responsible for administration of Lotus Notes database, section Medical Devices incl. uploading, distributions of QM-documents and follow up on
confirmations.
- Project Lead for ad-hoc Quality Management projects
- Preparation of Divisional Management Review
- Competence center and coaching in line with ISO 9001, ISO 13485, MDD and international guidelines concerning Medical Devices
- Provide expert assessment to Senior Management of critical Quality and Risk Management aspects
- Liaise with other functions (e.g. QA functions, business centers, etc.) to progress special projects, investigations or corrective actions where
appropriate

RESPONSIBILITIES

See above.

REQUIREMENTS

- Experience with Notified Bodies and CE Marking of Medical Devices
- Experience as a Medical Device Quality Auditor according to ISO 9001, ISO 13485, MDD and 21 CFR 820
- Degree in biomedical, mechanical or process based engineering
- 5-8 years experience in the Medical Device Industry
- Experience of business related travel and cultural sensitivity

- Profound Knowledge in International Medical Device Regulations, incl. ISO 13485 and International Guidelines
- Proficient in design a and maintenance of quality systems
- Fluent English, German and third language preferable
- Human relations ability is a critical requirement for this position
- Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’
- Capability to present the results of the quality assessments to all levels of Local/Regional/Global Management
- Flexibility in approach and ability to adapt to changing circumstances when required
- Ability for cross functional work with other global functions
- Excellent team player, decision making and problem-solving skills
- Financial awareness of cost of quality to business
- Available for domestic and international travel (max. 30%)

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.