DET QARA - Project Quality Engineer

le contenu du travail

【About Company】

SHL Medical is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.

【Job Overview】

Ensure full compliance, and solid product & process quality on design assurance of medical and non-medical connected device, software/firmware in medical device, and software component.

【Main Responsibilities】

• Be responsible for new project development quality, including auditing and tracking engineering quality
• Be responsible to integrate DHF documents for successful design transfer to CMO/customer.
• Collaborate closely with team member and keep making continuous improvement on quality system.
• Work with software and electronic SMEs to fulfill applicable technical standards
• Initiate action to prevent the occurrence of product non-conformity and system deficiency
• Any other tasks assigned by supervisor

【Required Skills & Qualifications】

• Higher diploma or Bachelor’s degree in Science or Engineering
• Good communication in English and analytical skills
• FamiliarizeISO13485,ISO14971, IEC62304
• Experience in cybersecurity, UL2900 and software risk assessment; IEC60601-1

【We Offer】

• Competitive compensation package.
• Modern working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast-growing and innovative industry.
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global