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Post Market Surveillance Quality Assurance Engineer
1 month ago
We are seeking a highly skilled Post Market Surveillance Quality Assurance Engineer to join our team at Intuitive Surgical. This is a unique opportunity to work in a dynamic environment where you will be responsible for ensuring the quality and safety of our medical devices.
About the RoleThe Post Market Surveillance Quality Assurance Engineer will be part of our regulatory and quality team, working closely with cross-functional teams to understand how our products and processes perform. Your role will involve collecting and analyzing data from various sources, including complaint files, risk management documentation, and CAPA files. You will also ensure that investigation documentation is complete and compliant with requirements.
As a key member of our team, you will have the opportunity to collaborate with other internal teams, such as Advanced Failure Analysis Engineering, Clinical Development, and Software Engineering. You will serve as a subject matter expert and on-site lead for PMS and Quality internal and external audits.
You will be responsible for managing your assigned complaint investigation workload to meet operational goals and executing QS and PMS projects. Your strong understanding of quality records requirements and documentation will be invaluable in this role.
Requirements- A minimum of 2 years of related experience in the Medical Device or Biomedical industry, with a university degree in Biomedical/Mechanical/Electrical/Robotic Engineering or equivalent;
- Proven experience in investigating issues, driving creative problem-solving related to product/process issues, and effectively documenting as needed;
- Strong understanding of quality records requirements and documentation;
- Experience collaborating effectively with product and/or process subject matter experts in a cross-functional team environment;
- Ability to navigate multiple activities with changing priorities and execute to required timelines;
- Proficient verbal and written communication in English.
In terms of salary, we offer an estimated $120,000 - $150,000 per year, depending on location and experience. This figure takes into account the cost of living in the Bay Area and the importance of attracting top talent in the field. If you are a motivated and detail-oriented individual who is passionate about quality and regulatory expertise, we encourage you to apply for this exciting opportunity.
At Intuitive Surgical, we believe in fostering a diverse and inclusive workplace culture. We are committed to equal employment opportunities and welcome applications from qualified candidates from all backgrounds.
