The Quality System Specialist is mainly responsible for handling quality system related activities including CAPA, QMS maintenance, Documentation Control and Training. In addition, working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules and guidelines.
What you will be doing:
- Developing and Administrating the QMS: designing, establishing, maintenance and continuously improving the (e)QMS, to meet or exceed the requirements of the relevant regulations. This includes development of policies, procedures, records’ handling and documentation to support the QMS.
- Managing Corrective and Preventive Action (CAPA) system: handling an effective CAPA system including all related activities
- Handling Training activities including overseeing and follow-up company employees training, ensuring meeting annual training plan and measuring training effectiveness
- Administration of Documentation Control activities, including generation, maintenance, review and approval, traceability and integration with the QMS, including follow up of related activities
- QA support of device labeling process verification and maintenance, including UDI
- QA support of translation process for products’ labeling information (IFUs, Labels, Marketing material)
- Participate in external audits and perform internal audits (lead auditor)
What you have:
- Bachelor’s degree in engineering, science or technical field or equivalent.
- Minimum 3 years of working experience in quality and regulatory fields in a highly regulated medical device industry (pharmaceuticals or biotechnology might also be considered).
- Excellent knowledge of Quality Management Systems, GMP, GxP, internal/external audits, CAPA, Change Control, Documentation Control, Training, Management Review, Risk management activities.
- Working experience with applicable and regulatory standards (including, but not limited to): ISO 13485:2016, MDR, MDSAP and 21 CFR QSR.
- Experience with root cause investigation methodologies (Fishbone, 5 Why’s, 8D)
- Strong oral and written communication skills (both in Hebrew and English).
- Demonstrated experience and proficiency with MS Office, electronic documentation management system, spreadsheets, presentations and database applications.
- Excellent collaboration and teamwork abilities with cross functional teams, e.g. R&D, RA, QA, Operations, Sales, Marketing etc.
- Exceptional multi-tasking skills, organized, attention to details, ability to collaborate and get things done in a fast-paced environment.
- Creative and independent problem-solving skills with high professional maturity.
Advantages:
- Knowledge of design controls methodology
- Certified lead auditor (per ISO 13485:2016 and/or MDR, MDSAP)
- CQE or CQM
Let us introduce ourselves
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company’s Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson’s Disease.
Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.
We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients. Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.
After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.
Top Skills
What We Do
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, Florida, with additional offices in Dallas, Shanghai, and Tokyo. Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.
