Validation Engineer

About us

Your Contribution

Owner of the validation system and the validation master plan.

• Defines and maintains the processes for validation/qualification and ensures they are properly documented.

• Leads validation projects, creates validation plans, coordinates the implementation and creates final validation reports.

• Identifies necessary re-validations over the life cycle and coordinates the measures required for these.

• Facilitates risk analyzes as part of the validation and suggests risk minimization measures.

• Generation of PFMEAs, Control plans and Process flow diagrams.

• Supports sales in negotiations with customers on the scope of validation of the technical documentation.

• Conducts necessary training on the validation process.

Your Profile

BS in Technical field or equivalent work experience.

• Minimum of five (5) years' experience in Quality Engineering or Management for medical products and validation processes.

• ISO9001/13485 experience.

• FDA 21CFR820, EU-MDD & MDR knowledge preferred.

• Strong technical writing skills.

• Ability to read and interpret technical drawings.

• Working knowledge of GD&T.

• Computer proficiency and experience using Microsoft Office software and SAP.

• Must be able to read, write, and speak English.

• Effective communication skills: listening, writing, speaking and oral presentations.

• Self-motivated and results oriented.

• Able and willing to work with others on a team, cross-departments and with customers.

• Due to the nature of work performed at this facility, US Person status may be required.

Your Benefits

At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.

Please feel free to contact us

At SCHOTT, it's your personality that counts - not your gender, your identity, or origin.