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GENEL NİTELİKLER

General Qualifications

Graduated from the fundamental science (Chemistry, Biology etc.) or engineering (Biomedical, Medicine etc.) departments of universities,

Minimum 1-2 years of experience in quality management area within production environment,

Full grasp of quality management systems based on ISO 9001:2015, experience with ISO 13485:2016 is highly preferred. (Knowledge about 2017/745/EU MDR and/ or 21 CFR 820 is an asset.)

Full grasp of quality analytical and statistical tools such as: D/P-FMEA, SPC, MSA, 8D, 5S, Ishikawa etc.

Able to work well in a team-oriented environment, solution-focused,

Analytical thinking and self-motivated,

Strong communication and coordination skills, enable a learning approach to solve problems,

Excellent knowledge of MS Office programs (Excel, Word, Power Point etc.)

Excellent command of written and spoken English,

Resident in İzmir,

No military obligation for male candidates.

Job Description

Planning, implementing and developing the quality management system according to ISO 13485:2016, 93/42/EEC and 98/79 /EEC Medical Device Directives,

Guiding company personnel on quality management system and quality policy,

Responsible for the creation of the technical files and keeping them up to date,

Work with relevant departments to ensure timely closure of quality actions / findings,

Actively contribute to continuous improvement initiatives.

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