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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!
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.
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.
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.
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.
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.