Job Description

• 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

• 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.