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BlueWind is looking for outstanding and talented candidates, to join us on our mission in developing a revolutionary medical device, that will improve dramatically the life quality of many people around the world.
It's time to make a difference - apply today!
General responsibilities include:
• Assist with development, deployment, and execution of Quality Policies, Quality Objectives, and Quality Plans
• Directly responsible for QMS activities including QA Training, Internal Audits, CAPA Process, Complaints, Change Control, and Document Control.
• Responsible for implementation, support, and maintenance of computer systems used for QMS processes
• Support the development and implementation of all QMS processes and procedures across company, including but not limited to; Design and Development, Risk Management, Purchasing & Supplier Quality, Process Control, Identification and Traceability, and Servicing
• Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement
• Representative for audits from external regulatory authorities and registration agencies
• Serve as a quality lead in project core teams
• Support quality goals and objectives along with activities to identify, explain and resolve quality issues.
Direct responsibilities on product development and testing, production and supply chain include:
• Support process and test method validation activities
• Lead root cause analyses and respond with corrective actions
• Develop and execute plans for quality and control to ensure constant manufacturing continuity and product conformance, including development and execution of statistical process controls utilizing quality tools and statistical techniques.
• Participate as Material Review Board member to review and define disposition of Non-Conforming Materials as suitable.
• Oversee inspection activities and supervise quality documents.
• Responsible for supplier qualification and audits with emphasis on challenging processes
• Responsible for ensuring equipment is calibrated and maintained on schedule
• Determine, implement, and monitor environmental conditions for production and warehouse facilities (including ESD program)
• Review DHR and perform Lot release
• Prepare, supervise and report suitable and effectual metrics monitoring.
• Engineering or Bachelor’s degree, preferably in an applicable technical discipline, formal education in Quality – an advantage
• 5 years of experience in Quality Assurance in medical device development and manufacturing environment, including exposure to FDA/ISO regulations (and standards such as ISO 13485, ISO 14971, 21 CFR 820/211, and MDD/MDR)
• Must have experience in developing, implementing, and maintaining effective Quality System Processes
• Must have specific experience in auditing. Lead auditor/qualification as an internal auditor an advantage
• Experience in writing procedures, creating management level presentations and reports
• Experience with Process validations (IQ/OQ/PQ), Test methods validations (TMV), design verification test methods development
• Experience with Root cause analysis of manufacturing failures and statistical analysis of manufacturing failures and NCRs (non-conforming materials)
• Prior hands-on experience with QA for manufacturing
• Prior experience with root cause analysis, Statistics, Lean Manufacturing, and Six Sigma
• Must be proficient in the use of Microsoft Office applications
• Prior experience with international companies -an advantage
• Ability to lead and influence others indirectly
• Assertiveness – capable of promoting changes
• Organized and methodic
• Detail oriented
• Strong interpersonal skills and ability to work in multi-disciplinary teams
• Strong verbal and written communication skills in English- mother tongue level
This is a full-time job, located in Herzliya Pituach.
Please send CV to firstname.lastname@example.org with the name of the position in the title of the email.