Test Validation Engineer
hace 1 día
We are seeking a skilled Test Validation Engineer to join our team at Coloplast. The successful candidate will be responsible for executing process validation, specializing in test method validation and test equipment within the organization.
Main Responsibilities- Maintaining the validation life cycle of machines, processes, test methods, and test equipment to ensure compliance with external and internal requirements.
- Issuing, completing, and/or approving validation documentation (protocols, deviations, reports, etc.).
- Performing Installation, Operational, and Performance Qualification of equipment, instruments, and processes as required.
- Validating test methods for continuous and attribute data; destructive and non-destructive tests.
- Assessing software changes and validating software as necessary on test equipment.
- Bachelor's degree in an Engineering field (e.g., Industrial, Electrical, Mechanical).
- Experience working with Quality system standards such as ISO 13485 and ISO 9001.
- Minimum 2 years of experience in regulated industries (e.g., medical device industry).
- Familiarity with Microsoft Office package (Word, Excel, PowerPoint, Outlook) and statistical software (e.g., JMP, Minitab).
- Fluent in both spoken and written English.
Coloplast is a global leader in developing innovative products and services that make life easier for people with intimate healthcare needs. We prioritize Closeness, Passion, and Respect in our approach to delivering solutions that improve quality of life for our customers.
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Quality Assurance Engineer
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Software Quality Assurance Specialist
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