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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!
Quality Assurance Lead/Manager
The QA lead/manager is responsible for all aspects of the Quality Management System (QMS), facilitating quality minded company culture and ensuring processes, products and services meet all external and internal quality requirements and are in compliance with regulations. The QA lead/manager interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment. The position reports to the VP QA/RA located in the US and requires on-going communications with a large team, based in the US, Europe and Israel.
RESPONSIBILITIES:
• Directly responsible for QMS activities including CAPA Process, Complaints, Manufacturing Deviation (NCRs), Change Control, Document Control, Internal Audits, Supplier Qualification and QA Training
• 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
• Assist with development, deployment, and execution of Quality Policies, Quality Objectives, and Quality Plans
• Responsible for supplier qualification and audits
REQUIREMENTS:
• Bachelor’s degree a must, formal education in Quality – an advantage
• At least 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 experience in leading or participating in audits
• Experience in writing procedures, creating management level presentations and reports
• Prior experience with international companies - an advantage
• Assertiveness – capable of promoting changes
• Detail oriented, organized and methodical
• Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly
• Strong verbal and written communication skills in English - mother tongue level
• Lead auditor/qualification as an internal auditor – an advantage
• Prior hands-on experience with QA for manufacturing – an advantage
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.
Quality Assurance Engineer
The QA Engineer is responsible for QMS activities with focus on Production and Supply Chain and Supplier Qualification, facilitating quality minded company culture and ensuring processes, products and services meet all external and internal quality requirements and are in compliance with regulations. The QA Engineer interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment.
The position reports to the VP QA/RA located in the US and requires on-going communications with a large team, based in the US, Europe and Israel.
RESPONSIBILITIES:
• Directly responsible for QMS activities including Production and Supply Chain, Supplier Audits and Qualification, Design and Development, CAPA Process, Complaints, Change Control, Document Control
• Support process and test method validation activities (OQ, PQ, TMV)
• 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
• Lead Material Review Board (MRB), define disposition of Non-Conforming Materials (NCMRs) 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
• Review DHR and perform Lot release
• Determine, implement, and monitor environmental conditions for production and warehouse facilities
• Prepare, supervise and report suitable and effectual metrics monitoring
REQUIREMENTS:
• Engineering degree, preferably in an applicable technical discipline, formal education in Quality – an advantage
• 5 years of experience in Quality Engineering in medical device development and manufacturing environment, including exposure to FDA/ISO regulations (and standards such as ISO 13485)
• Prior experience in internal or supplier auditing. Lead auditor qualification an advantage.
• Experience with Process Validations (IQ/OQ/PQ), Test Methods Validations (TMV), Design Verification Test Method development
• Experience in leading Root Cause Analysis (RCA) and statistical analysis. Lean Manufacturing, and Six Sigma – an advantage.
• Prior hands-on experience with QA for manufacturing
• Prior experience with international companies -an advantage
• Detail oriented, organized and methodical
• Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly
• 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.
Logistics Specialist
We are looking for a highly professional Logistics Specialist to join our team and support our global clinical study. The study is multi-site, multi-national, involving a large number of patients in Europe and US.
The position requires on-going communications with a large team, based both in the US Europe and Israel. We are looking for a service-oriented team member, with a can-do attitude and ability to solve problems and work under pressure.
This position is a part of the Operations department, reporting to the Clinical Project Manager.
This is a key position in the delivery of a leading multidisciplinary device that will improve dramatically the quality of life for many people around the world.
RESPONSIBILITIES:
• Responsible for the equipment logistics aspects of the company’s clinical trials
• Receive equipment from all internal and external suppliers
• Allocates equipment per field needs
• Single owner of the product allocation file: Register equipment in CTF, follows up on allocation status, manages allocation queue, etc.
• Responsible for shipments arrangements including documentation, pickup and follow-up
• Responsible for customs related processes
• On-going inventory management: levels, expiry dates, SW version, replacements, etc.
REQUIREMENTS:
• Practical Industrial engineering \ Logistics or equivalent experience
• 1-3 years of experience in operations, logistics, shipments, import\export or administration
• Advanced Excel skills (pivots, charts, advanced functions)
• Service oriented
• Meticulous with great attention to details
• Exceptional organizational and analytical skills
• Proactive with good communication skills
• Previous experience in a cross – functional role
• Agility and flexibility
• Highly organized
• Ability to collect, gather and analyze information
• Self-motivated and independent in his work
• Fluent verbal and written English
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.
Practical Electronics Engineer
The Practical Electronics Engineer will be a part of the hardware development team. He/she will be involved in various activities of development and technical support, focusing on product testing and investigation. The role requires hands-on capabilities, familiarity with lab equipment, proven ability to dive into details and work independently.
The position reports to the HW Leader.
RESPONSIBILITIES:
• Performing hardware investigations following customer complaints and manufacturing failures
• Performing tests as part of product development process
• Other functions as allocated by the HW leader
REQUIREMENTS:
• Practical Electronics Engineering graduate
• 3-5 years of experience in high-tech or medical devices industry
• Hands-on capabilities, familiarity with operation of lab equipment, experienced with soldering
• Experience in writing tests protocols, performing tests and writing report results (in English)
• Familiar with board design (Analog, Digital, Power) - an advantage
• Detailed oriented, organized and methodical, able to work independently
• Capable of prioritizing tasks and providing a timely schedule for completion
• Team player
• Strong verbal and written communication skills in English
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.
Senior System Engineer
The System Engineer is responsible for overall system architecture and design, system technical requirements, compliance with standards and regulatory guidelines, risk and hazard management, traceability, system verification and validation and system level failures problem solving. The role reports to the VP R&D.
RESPONSIBILITIES:
• Leads system and sub-system architecture, performance metrics, technical aspects of product manufacturing and service
• Defines system and sub-systems technical requirements and interfaces
• Leads and participates in risk and hazard analysis activities
• Identifies problems and leads the effort to solve system and sub-system levels issues
• Coordinates the integration efforts between hardware, software and mechanical functions including all sub-component interfaces
• Plans and guides verification and validation efforts, including compliance with standards and regulatory guidelines
REQUIREMENTS:
• MSc in Electrical Engineering, Physics or equivalent. PhD an advantage.
• Minimum 7+ years of experience in systems engineering of multidisciplinary electronic products
• Strong analytical and problem-solving skills
• Able to quickly learn and understand new concepts and background information
• Good grasp of system level, low level and their interplay
• Strong technical background in hardware, software, physics and mechanical design with focus on analog and digital electronics
• Able to write system and project documentation, including plans, design inputs, risk assessment, V&V docs
• Experience in implantable devices, wireless power transfer, systems that involve wearable devices - an advantage
• Able to plan ahead, take decisions and guide team progress
• Able to present ideas clearly and concisely at all levels within the organization
• Strong verbal and written communication skills in English
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.