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Job Description
Quality Assurance Specialist
Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements and industry standards.
Join a global team of over 70,000 employees working together to improve healthcare outcomes and experiences for patients worldwide.
About the Role
- Contribute and lead in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation.
- Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
- Focus on and be responsible for process quality design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
About the Company
Siemens Healthineers is a leader in the healthcare industry, with a portfolio spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world.
Requirements
- 5 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management.
- Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience.
- Experience in being a part of teams and projects with strong communications written and verbal.
Attributes and Skills
- High paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with key stakeholders.
- Strong skills and ability to influence cross-functional teams to drive workscope to completion.
- Self-starter, bias for action with ability to follow assignment through to completion.