מדעים/ביוטק

Manufacturing QA Engineer

218377

תאריך עדכון

24/11/2021

תיאור המשרה

We are looking for an experienced Manufacturing Quality Assurance Engineer to join our QA group and to support our meaningful growth. 

What will you do?

  • Provide quality support and guidance to Operations and Manufacturing teams, under quality system requirements.
  • Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
  • Review manufacturing records (DHR) as part of lot/batch release approval process.
  • Identify the opportunities for continuous improvement of the Quality System, specifically manufacturing processes.
  • Provide guidance and decisions on manufacturing activities to ensure compliance with internal procedure and regulatory requirements.
  • Take active role in planning process validation activities, and in production risk management (PFMEA).
  • Establish process of cascading critical characteristics (CTQ) into critical control points (CCPs), manufacturing process specifications and defining KPIs for these characteristics
  • Prepare supply chain related inputs for CRBs, Quality Management Reviews, etc.
  • Working and communicating with suppliers/ subcontractors in Israel and abroad, on production quality issues.
  • Responsibility on equipment calibration and maintenance definitions and activities.
  • Handling non-conformities detected in production, and participate in MRB committee.
  • Identify opportunities to proactively assure compliance to international quality regulations e.g., ISO 13485, ISO14971, US 21 CFR 820 etc.
  • Define and implement process control & monitoring over Manufacturing.

What do you need to bring with you?

  • Bachelor’s degree in Electrical/Mechanical/Biomedical Engineering (or equivalent)
  • 3+ years of experience in Quality Assurance at Medical Device companies, producing sterile, biocompatible, electromechanical products which include software (active implants companies – an advantage).
  • Familiarity with international quality regulations – ISO 13485, ISO 14971, US 21 CFR 820 etc.
  • Ability to partner with Manufacturing and Operation departments and collaborate with various departments within the organization.
  • Significant experience in providing QA/QC support and guidance to manufacturing, including in-process and final inspections. (Manufacturing in clean room – an advantage)
  • Experience in working and communicating with suppliers/ subcontractors in Israel and abroad, on production quality issues. (Suppliers audit experience – an advantage)
  • Experience in production risk management and process validation.
  • Experience in writing and reviewing manufacturing procedures/ work instructions/ forms related to manufacturing processes.
  • Experience in batch/lot release, including reviewing manufacturing records, route cards, inspection reports, sterilization records (DHR).
  • Experience in writing and reviewing engineering/design changes (ECO).
  • Experience in writing and reviewing engineering/design changes (ECO).
  • Experience handling non-conformities (NCR/MRB) in production.
  • Experience in reviewing and approving equipment calibration reports.
  • Technical writing skills.
  • Languages: English – excellent level
  • An ability to successfully communicate and educate QMS regulations, policies and strategies to employees at all levels of the organization.

  

שלח קורות חיים
המשרה מיועדת לנשים ולגברים כאחד