Search in site
Careers
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!
Quality Assurance Engineer
BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The BlueWind device is a unique and complex product, including embedded software of a wearable RF-transmitter device, embedded software of an active Implantable medical device, and iOS/android-based applications software for programming and controlling the whole system. We are working in dynamic, multidisciplinary and multi-project environment
The QA Engineer is responsible for the planning and execution of quality assurance activities ensuring that processes, products and services meet all external and internal quality requirements and are in compliance with regulations.
This position is supporting management and team in all aspects of the Quality Management System (QMS), with focus on product development and testing, production and supply chain, activities to:
• Facilitate quality minded company culture
• Ensure that regulatory, statutory and customer requirements are met for processes and products
• Identify and follow up on correction of product nonconformance and process noncompliance situations
• Identify and implement opportunities for improvement to product and processes
This position interacts with all functions and levels throughout the company and outside the company. Internally, the QA Engineer works closely with R&D and Production to plan, execute, and monitor compliance with QMS. Externally, the QA Engineer interacts frequently with sub-contractors and suppliers when qualifying, auditing and overseeing their work. In addition, the Quality Manager interacts with regulatory agencies that are responsible for auditing the company’s quality system.
This is a key position in maintaining and improving the quality system of a company that its leading device will improve dramatically the quality life of many people around the world.
This position reports to the VP QA/RA
RESPONSIBILITIES:
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.
REQUIREMENTS:
• 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 info@bluewindmedical.com with the name of the position in the title of the email.