Quality Assurance Engineer

RANDSTAD SEARCH ANDSELECTION PER SEÇ VE YER LTD ŞTİ

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