Quality Management Specialist Germany (m/f) in Duisburg at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Your key responsibilities:

  • Quality Assurance.

  • Ensure that the Quality Management System is implemented and maintained in accordance with the requirements of the ISO 9001/13485 and the Stryker EU QA guidelines and procedures.

  • Organize at fixed intervals, formal Management reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness.

  • Report on the performance of the Quality Management System, including needs for improvement.

  • Ensure the control of the Quality Assurance documentation as needed

  • Plan and perform internal audits on a regular base

  • Ensure awareness of customer requirements throughout the organisation to consistently provide products and services that meet customerers expectation.

  • Address and evaluate customer satisfaction through the effective operation of the system, including continuous improvement.

  • Local and EMEA Quality procedure development and implementation according to the Divisional Policies.

  • When / If applicable, ensure that subcontracted distributors are regularly audited and perform in line with Stryker requirements.

  • Coorperate with global QMS teams and support or lead key initiatives in EMEA.

  • Develop and perform training on QMS related topics to other Stakeholders acoss the Organisation.

  • Post Market Surveillance.

  • Ensure that the Stryker EU post marketing vigilance SOP’s are properly delivered and implemented.

  • In line with these procedures, liaise with the relevant authorities and with Customers when Complaints / product liability matters occurs.

  • Ensure that product legacy data (products traceability) are consistently and safely maintained.

  • Monitor the closure of RA actions initiated for Poland and/or other regions and report progress as appropriate to local and European stakeholders.


What we are looking for:

  • Fluent in German & English (additional language desirable)

  • Degree graduate (Science/ engineering/business fields) or no less than 5 years experience working in QA for a Medical Device or Pharmaceutical Organization

  • Qualification / certification in QMS auditing for ISO 13485 and/or ISO 9001

  • Proven Expertise in ISO 13485 Quality Management Systems and MDD vigilance

  • Well established communication skills with key stakeholders

  • At least several years of working experience in a a Medical Device or Pharmaceutical Organization

  • Proven and measurable track record on projects within RAQA environment (eg. CAPA/CARA, process improvements)

  • Work to strict deadlines and under pressure. 

  • Ability to develop and execute plans / processes

  • Analytical & customer service skills

  • Ability to influence and inspire others

  • Accurate and concientious

  • Creative but realistic

  • Ability to prioritise and organise own workload

  • Ability to analyse data and statistics



Work From Home: No

Travel Percentage: Up to 25%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team