Beschreibung
Our client is currently looking on an experienced validation engineer to support a project related to validation and verification activities for medical devices products.RESPONSIBILITIES: daily tasks:
Strong engineering skills with working knowledge of Process validation/verification activities
experience in creation of protocols and reports for IQ, OQ, PQ, Test Method Validation (TMV) or Software Validation
Collaborate with other departments (Manufacturing, Engineering, Inspection, logistic…) to ensure proper execution of the validation and the tests
maintain products/processes that are aligned with the overall Quality and Business vision.
Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality.
Problem solving techniques including 8D, root cause analysis and cause and effect analysis.
EXPERIENCE REQUIREMENTS:
Degree in Engineering or in a related technical/scientific discipline is required.
Ability to work independently and partner with a cross-functional team (supplier, R&D, Regulatory, Manufacturing, and Purchasing etc).
Expereince with Risk management methodology
Prior epxeirence in manufuctruing setting in medical devices
Understanding of the NPI (New Product Introduction) process and Process Validation
expertise
Ability to provide regular updates to project leader and team at various forums
A thorough understanding of GMP/ISO regulations and validation regulations
Organizational talent, reliability, dependability, personal initiative, customer / service orientation.
Working knowledge of Microsoft office products (Word, Excel, Access, and Project etc).
Language: English and German mandatory
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.