Independent planning, coordination and implementation of necessary qualification and validation activities related to all production and support processes including corresponding documentation
Validation activities during the projects including evaluation of test results and change/deviation management (e.g. for Production equipment, systems, software, peripherals, buildings and facilities etc.)
Monitoring of the required quality activities around the Validation activities (e.g. ordering test equipment, material qualification, supplier matters)
Creation of corresponding documentation according to the work instructions
Support and, if necessary, organization of risk management activities within the projects
Changes evaluation in terms of their impact on the qualified/validated state
Carry out requalification activities
Creation of customer declarations etc. (possibly in cooperation with others positions e.g. Regulatory Affairs)
Create and maintain test/sample sets
Support for internal audits, customer audits and if needed supplier audit
Contribution to new procedures, procedure updates and improvements (process descriptions work instructions)
Qualifications
Qualifications
Knowledge as typically acquired during at least 3 years of technical university studies (e.g. mechanical engineering, industrial engineering, or similar) and extended by at least 5 years of relevant professional experience in the areas of quality assurance, qualification and/or validation.
This function requires special knowledge in the areas of verification and validation of processes & qualification of equipment.
1-2 years of experience using project management methods
1-2 years of using statistical QM methods
1-2 years of experience working with IT applications (e.g. Office programs, MES, QM system)
Knowledge of quality management, QM methods and QM guidelines
Knowledge of problem-solving methods (e.g. KT)
Good technical understanding in dealing with specifications
Excellent analytical competence (especially in the field of interpretation of results and derivation of further measures)
Fluent in English
Additional Information
Mon - Fri / 40hrs
company health benefits, 401k, incentive bonuses
All your information will be kept confidential according to EEO guidelines.