לוח משרות דרושים מנהל איכות | מנהל QA

Requirements:
* Experience of at least 10 years in a similar role in the Medical Device industry
* BSC in Engineering or Sciences
* Work experience with multi-disciplinary Systems
* Regulatory experience with CE and FDA standards
* Strong level of English (read, write and verbal skills)

Requirements:
* Minimum of 5 years of quality assurance experience in production processes within a manufacturing company
* Experience in implementing and managing quality assurance metrics
* Familiarity with ISO 9001:2015 regulations, automotive industry standards (IATF 16949, VDA 6.3), CAPA, and automotive core tools (e.g., FMEA, APQP, PPAP, SPC, MSA)
* Excellent problem-solving, interpersonal communication, and project management skills (8D, Ishikawa, 5W)
* Ability to lead cross-functional organizational processes
* Certified 1st and 2nd party auditor for IATF 16949; VDA 6.3 auditor certification preferred
* Strong technical skills
* Proficiency in Microsoft Office tools, particularly Excel
* High proficiency in written and spoken English **This position is hybrid: 4 days from the office and 1 day from home**

Requirements:
Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
At least 5 years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
Ability to collaborate effectively with cross-functional teams to achieve quality objectives
A motivated, collaborative, and proactive approach to work
Team orientation
Excellent communication skills (both written and verbal)
Strong attention to detail
Ability to lead and implement processes
English proficiency

Requirements:
Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
At least three years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
Ability to collaborate effectively with cross-functional teams to achieve quality objectives
A motivated, collaborative, and proactive approach to work
Team orientation
Excellent communication skills (both written and verbal)
Strong attention to detail
Ability to lead and implement processes
English proficiency

Requirements:
We are looking for a highly motivated and experienced Software Quality Assurance Team Leader to manage and guide our dynamic SW QA team. In this leadership role, SW QA team lead will be responsible for driving quality initiatives, mentoring team members, and collaborating with cross-functional teams to ensure the quality, reliability, and performance of software integrated into our ophthalmic robotic surgery platform. This is an ideal opportunity for someone who is motivated and passionate to make an impact in leading the development of the next generation of ophthalmic robotic surgery. Responsabilities
Lead and mentor the SwQA team, fostering a collaborative and results-oriented environment.
Define and implement quality assurance strategies, processes, and best practices.
Oversee the execution of various types of software tests, including functional, integration, regression, and performance tests, both manually and with automated testing tools.
Monitor and manage defect reporting, tracking, and analysis to enable timely resolution.
Ensure comprehensive documentation of test results and reports, maintaining clear traceability between software requirements and test procedures.
Collaborate closely with development teams for early identification of quality-related issues and for improving software development processes.
Continuously evaluate and recommend improvements to testing tools, methodologies, and workflows. Requirements
BSc Degree.
8+ years of experience in Software Quality Assurance.
At least 2 years in a leadership or managerial role, preferably in the medical device industry.
Extensive experience in software lifecycle.
Strong expertise in both manual and automation testing techniques.
Proficiency in various testing types, including functional, regression, performance, and integration testing.
Solid understanding of software development processes, QA methodologies, and best practices.
Proven ability to lead and motivate a team, ensuring alignment with project goals and timelines.
Excellent verbal and written communication skills in English.
Strong problem-solving abilities, attention to details, and the ability to quickly learn new technologies and systems.

Requirements:
Minimum of 5 years of quality assurance experience in production processes within a manufacturing company.
Experience in implementing and managing quality assurance metrics.
Familiarity with ISO 9001:2015 regulations, automotive industry standards (IATF 16949, VDA 6.3), CAPA, and automotive core tools (e.g., FMEA, APQP, PPAP, SPC, MSA).
Excellent problem-solving, interpersonal communication, and project management skills (8D, Ishikawa, 5W).
Ability to lead cross-functional organizational processes.
Certified 1st and 2nd party auditor for IATF 16949; VDA 6.3 auditor certification preferred.
Strong technical skills.
Proficiency in Microsoft Office tools, particularly Excel.
High proficiency in written and spoken English.