Quality System Specialist

Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing in and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With over 450 employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo, and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.

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