Qualification and Validation Engineer
vor 1 Tag
We are excited to announce an opportunity to join our client's dynamic team in Rotkreuz as a Q&V Engineer within the Manufacturing Science & Technology (MSAT) department for Sensors & Cartridges. Our client is seeking a dedicated professional who thrives in a fast-paced, agile environment and is passionate about compliance and quality assurance. If you are looking for a role that offers variety, challenges, and the chance to make a significant impact, we encourage you to apply and become a valuable member of this innovative team.
Responsibilities:
- Plan, coordinate, and implement qualifications for equipment ranging from small devices to complex large systems, including creating and moderating risk analyses.
- Plan, coordinate, and implement process and method validations, as well as requalifications and revalidations in the context of changes.
- Serve as the contact person for other teams regarding compliance and evaluation of qualification or validation needs.
- Independently communicate and gather information from various stakeholders.
- Support the processing and implementation of deviations within the S&C sensors and reagent production.
- Ensure compliance with existing framework conditions, regulatory requirements, and area-specific requirements.
- Prepare for audits and successfully represent the Q&V Chapter during audits.
- Support the definition of quality-relevant requirements within CAPEX projects.
- Independently identify and eliminate inefficient processes within the chapter and MSAT.
Requirements:
- University diploma or B.Sc. or M.Sc. in natural or engineering sciences or equivalent training with relevant professional experience.
- At least 1 year of professional experience in a regulated environment.
- At least 1 year of professional experience in the field of qualification of equipment and systems.
- Experience in the field of validation of manufacturing processes is an advantage.
- High level of quality awareness and in-depth experience in creating quality-relevant documents.
- Good to very good knowledge of creating risk analyses and a strong technical understanding.
- Fluent in written and spoken German, with very good written and spoken English (B2) required.
PLEASE NOTE:
- Due to the high volume of applications only shortlisted candidates will be contacted.
- Candidates must have the right to work in CH (B permit or EU citizenship).
- German language proficiency is a MUST HAVE requirement.
Entry level
Employment typeFull-time
Job functionMedical Equipment Manufacturing
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