Quality Assurance Manager
Under the direction of the Quality Director Go To Market EMEA, the Senior Quality Manager EMEA QMS Center of Excellence will be responsible for the development and/or maintenance of a standardized quality system meeting all applicable internal and external requirements.
Client Details
Our client is one of the largest, global, medical technology companies in the world.
Description
- Responsible for facilitating the implementation of one QMS in accordance to company strategy. Responsibility includes assuring that the quality system remains updated to reflect any change in regulatory requirements. Responsible for ensuring that appropriate processes and procedures are implemented. Standardization of the EMEA local procedures and development of regional procedures in alignment to the company strategy.
- Develop metrics for the monitoring of the regional QMS
- Responsible for maintaining the ISO certification in the EU Shared Service Center in Wroclaw and to act as QA Management Representative.
- This role will be responsible for a team of 11 employees responsible to maintain both the regional QMS and the local QMS in EU Shared Service Center in Wroclaw.
- Responsible for addressing issues and influencing decisions. Provide interpretation of existing and emerging regulations and make recommendations for changes in quality systems, policies or procedures to a minimum standard set by Central.
- Lead and/or facilitate and support regional and corporate quality projects
Profile
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
- Minimum of 10 years of experience in quality management with at least 5-7 years of compliance management experience.
- In depth knowledge of European Medical Device Directive and Medical Device Regulation as well as ISO 9001:2015 and ISO13485:2016
- Excellent written and oral communication and organizational, project management skills.
- Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
- "Out of box" strategic thinker with strong leadership ability to navigate in complex matrix , breaking barriers and empowering strong teams.
- As a change agent, motivated to improve organizations and not be satisfied with status quo.
- Strong intellectual curiosity and pursuit of knowledge. Cultivates new ideas. Comfortable with ambiguity and uncertainty.
Job Offer
- work in mutinational environment
- benefit package
- flexible working time
Please apply via the button on the right side of this job offer.
Job details
Location: Wrocław
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Location: Wrocław
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Follow us on:
