PROCEPT BioRobotics · 1 day ago
Senior Supplier Quality Engineer
San Jose, CA
Full-time
Onsite
Mid, Senior Level
$127K/yr - $149K/yr
5+ years expPROCEPT BioRobotics is dedicated to revolutionizing treatment for benign prostatic hyperplasia through surgical robotics innovation. The Senior Supplier Quality Engineer will ensure the quality and reliability of devices by working with cross-functional teams and maintaining compliance with regulatory standards while fostering partnerships within the supply chain.
Health CareManufacturingMedical DeviceRobotics
No H1B
Responsibilities
Conduct supplier assessments and audits to evaluate their capabilities, processes, and quality management systems to meet Procept and regulatory requirements
Assist in the selection and qualification of new suppliers based on established procedures
Develop periodic reports on supplier performance (scorecards). Establish and maintain periodic reviews with suppliers on their performance, and improvement plan
Maintain detailed records of supplier audits, quality performance, and corrective action plans
Report on supplier quality performance during cross-functional meetings and provide recommendations for improvement
Create supplier quality reports, including analysis on defect trends, root causes, and long-term resolutions
Ensure effective implementation of corrective actions and track results to ensure continuous improvement
Lead resolution of supplier related non-conformances using problem solving tools (8D, Fishbone, 5 WHY’s, etc.)
In-depth understanding of manufacturing processes, including machining, fabrication, casting, injection molding, and assembly processes
Ability to assess the quality impact of supplier manufacturing changes and deviations
Must have excellent problem-solving abilities using systemic, logical, and sequential approaches and provide technical oversight for issue/problem resolution activities
Comprehensive knowledge of TMV’s, process and product validations (i.e., IQ, OQ, PQ). Ability to independently execute supplier process validation
Advanced knowledge of quality management tools, including, but not limited to (SPC, FMEA, MSA, DOE, and Quality Systems)
Support continuous product and process improvement through detailed failure analysis for nonconformance's, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
Work closely with R&D, Procurement, Manufacturing, and Regulatory Affairs on supplier-related initiatives
Support New Product Introduction with supplier readiness and capability assessments
Qualification
Required
Bachelor's degree preferably in an engineering or scientific discipline
5+ years' experience working in manufacturing of finished medical device or related industry
Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, and the EU Medical Device Directive
Lead auditor credentials for QSR, ISO, or MD SAP, and EU MDR are desired
(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
Knowledge of probability, statistical quality control and design of experiments, Minitab proficiency preferred
Knowledge of geometric design and tolerance (GD&T) and gage design tolerance preferred
Six Sigma Green or Black Belt certification
Strong analytical, problem-solving, and communication skills
Ability to travel up to 25% domestically and internationally for supplier audits and visits
Preferred
Lead auditor credentials for QSR, ISO, or MD SAP are desired
Knowledge of probability, statistical quality control and design of experiments, Minitab proficiency preferred
Knowledge of geometric design and tolerance (GD&T) and gage design tolerance preferred
Benefits
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
Company
PROCEPT BioRobotics
PROCEPT BioRobotics is a surgical robotics company that develops water-based robotic systems for prostate surgery.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$820.34MKey Investors
CIBC Innovation BankingFidelityViking Global Investors
2024-10-29Post Ipo Secondary· $175M
2023-08-01Post Ipo Equity· $150M
2022-10-10Post Ipo Debt· $52M
Leadership Team
Mohan F. Sancheti
Vice President Operations
Recent News
thefly.com
2025-12-09
2025-11-07
PROCEPT BioRobotics
2025-11-05
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