Design QA Team Leader (Bio-Engineering)

A fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Design QA Team Leader to join our winning QA team
Job Description:
• You will lead the QA Design team and have full control over the execution of R&D processes, according to the internal SOPs and regulatory requirements, in cooperation with RA department.
• Responsibility over QA work in the following areas: Design control, DHF, MP, ECO, CSV, QP, Waiver, QRB, PN issuing, Archive, eQMS maintenance
• Support over QA work in the following areas: EOL, Calibration
• Act as a QA focal point for Administration sets production changes
• Act as Management representative delegate in COCO, ECO, MP meetings
• You will participate in product development cycle by reviewing and approving project documentation
• Work closely with R&D to develop appropriate qualifications for new products and changes to released products,
• Interface also with product management, Engineering, and production teams to bring the new products to the market, and support production processes changes (i.e. Mold validation, PV, sterilization validation)
• Hands-on, professional support and resource allocation management of QA members for change controls which are initiated for R&D and commercial products
• Leading and supporting internal auditing processes and suppliers auditing in local and abroad production sites
• Supporting the initiation and implementation of quality plans related to the company’s QMS
• Monitoring, analysis, and presentation of QA Design KPIs
דרישות התפקיד
• Education: Relevant degree in Biotechnology/Bio-Engineering – a must
• Job skills:
o 3–5 years of experience in the medical device industry is required
o 2 years of managerial experience
o Experience working under of ISO 13485:2016, FDA requirements (e.g., CFR Part 820) and EU Medical Device Regulation (MDR)
o Effective problem-solving skills to lead and influence others to drive change
o Ability to work independently with minimal supervision
• Computer skills: Computer skills (Microsoft Word, Excel, PowerPoint)
• Language skills: High level of English - written and spoken