Senior Quality Assurance 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.

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:

• 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