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 and Regulatory 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 an international company working in a dynamic, multi-disciplinary and multi-project environment The QA and RA 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. QA & RA Engineer supports management and team in all aspects of the Quality Management System (QMS) 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 & RA Engineer works closely with R&D and Production to plan, execute, and monitor compliance with QMS. Externally, the QA & RA 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:

• 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

• Collect, analyze, and present data on the QMS status during Quality and Management Review Meetings

• Representative for audits from external regulatory authorities and registration agencies

• Responsible for supplier qualification and audits

• 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

• Serve as a quality lead in project core teams

 

REQUIREMENTS:

• 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

• Must be proficient in the use of Microsoft Office applications

• Prior hands-on experience with QA for manufacturing – an advantage

• Prior experience with root cause analysis, Statistics, Lean Manufacturing, and Six Sigma – an advantage

• 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.

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