sterilization quality assurance engineer

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We are looking for a "Sterilization Quality Assurance Engineer" for our multinational customer.

Ensure compliance to the sterilization related regulations, especialy ISO 11135 and ISO 11137 where applicable.
Interprets updates to applicable international standards related with sterilization and guidelines and implements them into the quality system.
Responsible to overview all the sterilization processes executed by the manufactuing site or the qualified subcontractors.
Review and approve sterilization validation/requalification activities including equipment validation/qualifications (IQ, OQ and PQ).
Follow up and support routine sterilization activities.
Ensure requalification activities related to medical devices and combination products are performed on a timelly manner.
Review/approve product and process change control documentation and specifications,provide required inputs from sterilization process perspective.
Ensure compliant implementation of the process/product chnages from sterilization eperspective.
Coordination of sterilization qualification and requalification activities with sterilization vendors and sterilization operation team.
Collaborating with team members and overseeing external partners (contact sterilizers,testing labs, etc) to achieve process/project objectives.
Reviewing and evaluating process issues, performing root cause analyses in case nonconformitieshappen and implementing process improvements.
Applying Engineering/Scientific/GMP theories, principles techniques to solve problems.
Responsible for providing engineering support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility.


B.S./M.S/Ph.D. degree in science, engineering, or a related field.
Preferably, minimum 3 years total work experience with at least 1 or more years’ relevant experience in healthcare/ biotech/ medical devices/ pharmaceutical industry.
Knowledge of tools/ methodologies such as sterilization validation, investigation methods, process validation, statistical process control (SPC), protocol/ report preparation.
Knowledge of ISO 13485, ISO 11135, ISO 11137, ISO 11737-1 and FDA requirements.
Good knowledge of MS Office applications is required and SAP is an asset.
Good command of English is compulsory, German knowledge would be an asset.
Communication skills, ability to work in a team environment.
Ability to work with multi- departmental project teams and resolve quality related issues in a timely and effective manner.
Strong problem solving ability.
Ability to work with external partners is required.
Technical drawing interpretation.
Good communication skills, able to establish and maintain effective working relationship.
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