דרושים » ייצור ותעשייה » Production Quality Assurance Engineer- Medical Device

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פורסם ע"י המעסיק
15/09/2019
Location: Ramat Gan
We are looking for a reliable Production Quality Assurance Engineer to ensure that all external requirements are met before our product reaches our customers. You will be responsible for inspecting procedures and outputs and identifying mistakes or non-conformity issues. Duties and Responsibilities · Oversee all production quality processes, including oversight of contract manufacturers. · Partner with engineering and operations teams in NPI processes and ongoing quality improvement initiatives · Analyze and present supplier quality metrics · Perform suppliers' certification and annual audits according to an annual plan. · Support company QMS activities eg CAPA, customer complaints, MRB, audits as required. · Executed risk analyses with control plan (PFMEA) · Control ECO process including managing and reviewing ECO · Other tasks related to Production and QC department, as deemed necessary. Working hours Full-time job. The position requires travelling to suppliers in the north of Israel and abroad. Report to : QA Manager. Interfaces with : Operations, Hardware, SW, Clinical & Regulation.
Requirements:
· BSc in engineering or Certified Quality Engineer (CQE) - Mandatory · At least 2 years' experience in suppliers' and production quality management in a medical device company. · Familiar with ISO13485, FDA QSR 820 standards · Experience in participation in external and internal audits – an advantage · Certified auditor – an advantage Essential Attributes: · Fluency in English & Hebrew – spoken and written · Strong attention to detail and accuracy · Well organized with an understanding of priorities and changing demands · Highly motivated, team player, passionate with independent learning and working abilities
 
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