PROCEPT BioRobotics
This range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $100,000.00/yr - $118,000.00/yr
Company Overview Embark 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 detail-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
Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field), Life Sciences, or equivalent experience
1–3 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
Understanding PROCEPT's Culture At 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 being humble and highly engaged. We continue with our live induction program, etc.
BENEFITS OF WORKING AT PROCEPT! PROCEPT’s health and wellness benefits for employees are second to none in the industry. Comprehensive benefits include medical coverage, wellness programs, on-site gym, 401(k) plan with employer match, disability coverage, life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT PROCEPT 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 TRANSPARENCY Procept 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. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.
WORK ENVIRONMENT We’ll 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. ...
Artificial Intelligence Hiring Note We may use artificial intelligence (AI) tools to support parts of the hiring process ...
Compensation Note Compensation also includes a 10% annual bonus, flexible time off, and RSUs at offer! Work Authorization Status: Citizen / Permanent Resident.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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Base pay range $100,000.00/yr - $118,000.00/yr
Company Overview Embark 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 detail-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
Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field), Life Sciences, or equivalent experience
1–3 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
Understanding PROCEPT's Culture At 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 being humble and highly engaged. We continue with our live induction program, etc.
BENEFITS OF WORKING AT PROCEPT! PROCEPT’s health and wellness benefits for employees are second to none in the industry. Comprehensive benefits include medical coverage, wellness programs, on-site gym, 401(k) plan with employer match, disability coverage, life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT PROCEPT 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 TRANSPARENCY Procept 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. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.
WORK ENVIRONMENT We’ll 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. ...
Artificial Intelligence Hiring Note We may use artificial intelligence (AI) tools to support parts of the hiring process ...
Compensation Note Compensation also includes a 10% annual bonus, flexible time off, and RSUs at offer! Work Authorization Status: Citizen / Permanent Resident.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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