Quality Engineer, Sustaining at PROCEPT BioRobotics – San Jose, California

Quality Engineer, Sustaining

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You: Do you want to be part of an innovative, cutting edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.What Your Day-to-Day Will Involve

• Quality Operations & Compliance
• Support manufacturing operations by ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Perform line clearance, in-process inspections, and final release activities under guidance from senior engineers.
• Assist with nonconformance investigations (NCMRs), including data collection, basic root cause analysis, and documentation.
• Support cleanroom controls and environmental monitoring activities to maintain compliance with Class 8 cleanroom requirements.
• Assist with execution of process validations (IQ, OQ,PQ) and data analysis for validation and qualification activities.
• Continuous Improvement & Risk Management
• Participate in risk management activities (e.g.,pFMEA updates, control plan reviews) under the direction of senior engineers.
• Identify and communicate potential quality issues or process improvements to reduce defects and improve yield.
• Support cross-functional teams in resolving day-to-day quality and production challenges. Regulatory & Documentation
• Maintain accurate and complete quality documentation, including inspection records, work instructions, and quality procedures.
• Support internal and external audits (FDA, ISO, MDSAP) by preparing records and assisting with audit responses.
• Assist with new product introduction (NPI) activities by supporting design transfer and process validation requirements.

The Qualifications We Need You to Possess

• Bachelors degree in Engineering (Mechanical, Biomedical, Industrial, or related field), Life Sciences, or equivalent experience.
• 13 years of experience in quality, manufacturing, or engineering in a regulated environment (medical device preferred).
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Basic understanding of root cause analysis tools (e.g., 5-Why, fishbone) and nonconformance investigations.
• Ability to read and interpret engineering drawings and use basic metrology tools (calipers, micrometers).

Preferred Skills:

• Experience in medical device manufacturing (Class II or III devices).
• Knowledge of process validation (IQ, OQ, PQ) and statistical tools (SPC, Gage R&R, AQL).
• Experience with MES or eDHR systems.
• Exposure to cleanroom operations and environmental monitoring.

Compensation also includes a 10% annual bonus, flexible time off, and RSUs at offer!Work Authorization Status: Citizen / Permanent ResidentUnderstanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesnt happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procepts history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics wont just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world! BENEFITS OF WORKING AT PROCEPT! PROCEPTs health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENTWell provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
PROCEPT BioRobotics Applicant Privacy NoticeWhen you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, rsum or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role. To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].
$101,390 - $119,280 a year