Quality Assurance Engineer İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
We are looking for a "Quality Assurance Engineer" for our multinational customer who operates in the medical sector.
İŞ TANIMI:
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
GEREKLİLİKLER:
We are looking for a "Sterilization Quality Assurance Engineer" for our multinational customer who operates in the medical sector.
İŞ TANIMI:
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
GEREKLİLİKLER:
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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