Senior QA Specialist

What you will be doing:

Job Description, the position is in the Quality Department, with emphasis on supporting R&D and TTP activities.

The function also includes typical QMS activities. The job holder's duties and responsibilities include the following:

SPECIFIC R&D RELATED ACTIVITIES

Quality focal point for supporting R&D and engineering activities, from feasibility stage to product industrialization, along the product lifecycle, including software (not including QA/ QC testing)
Quality focal point for change control process, providing inputs and guidance, based on current practices and according to procedures, addressing related risks and mitigations
Capability of supporting TTP (transfer to production) and NPI (new product introduction) processes, implementing process validation, FAI, DFMEA and PFMEA , pilot processes or equivalent
Supporting DHF, DMR and DHR completeness and correctness documentation in all product's lifecycle stages

QA RELATED ACTIVITIES

Generating and updating procedures, protocols, reports and associated quality related documentation
Capability to generate training materials and provide training in quality related matters
Active participation in internal, external and suppliers' audits, from preparation to reporting
Participation in regulatory inspections (e.g. 21CFR820. ISO13485, MDD, MDSAP, MDR), and other external and internal audits, including investigations and further CAPA and corrections

MISCELLANEOUS ACTIVITIES

Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules
QA designee and other tasks as assigned according to the professional background and company needs

What you have:

At least 10 years of experience in medical devices, pharmaceutical, biology/ biotech or cosmetics industries, in quality.
Relevant formal education and strong background in quality, quality engineering, engineering, and/ or relevant medical products or processes.
Very familiar with automated (software) quality systems, and ERP platforms (such as Priority or SAP)
Background on quality systems standards, such as 21CFR 820 and ISO 13485, MDSAP, MDR
Familiar with risk management process and ISO 14971
Background on SW development and ISO 62304
Experience with quality audits (internal/ external)
High level of written and spoken English

Advantages:

Specific relevant experience in Medical Device industry
CQE/ CQM is preferable
Auditor certification is preferred
Background in statistics for quality analysis is a plus
Experience with supplies control quality management
Background on sterile process and products, especially with ETO/EO

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.