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%

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