PROCEPT BioRobotics
Senior Supplier Quality Engineer
PROCEPT BioRobotics, San Jose, California, United States, 95123
Job Overview As a Senior Supplier Quality Engineer, you have 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, and EU MDR. You will build a partnership culture with the supply chain with transparency, coaching, and adapting to our continuous improvement philosophy. Being detail- and solution-oriented, proactive, and self-managed will assist in the success of this position.
Is this the role you are looking for If so read on for more details, and make sure to apply today. This role is with PROCEPT BioRobotics, focused on revolutionizing treatment for benign prostatic hyperplasia (BPH) through surgical robotics, with a patient-first focus and opportunities for career growth. What Your Day-To-Day Will Involve
Conduct supplier assessments and audits to evaluate capabilities, processes, and quality management systems to meet Procept and regulatory requirements. Assist in selecting and qualifying new suppliers based on established procedures. Develop periodic supplier performance reports (scorecards) and establish periodic reviews with suppliers on performance and improvement plans. 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 for continuous improvement. Lead resolution of supplier-related non-conformances using problem-solving tools (8D, Fishbone, 5 WHY’s, etc.). Demonstrate in-depth understanding of manufacturing processes, including machining, fabrication, casting, injection molding, and assembly processes. Assess the quality impact of supplier manufacturing changes and deviations. Provide technical oversight for issue/problem resolution activities with strong problem-solving abilities. Understand TMV’s, process and product validations (IQ, OQ, PQ) and independently execute supplier process validation. Apply advanced quality tools (SPC, FMEA, MSA, DOE, and Quality Systems). Support continuous product and process improvement through failure analysis for nonconformances and development of corrective/preventive actions. Collaborate with R&N, Procurement, Manufacturing, and Regulatory Affairs on supplier-related initiatives. Support New Product Introduction with supplier readiness and capability assessments. Qualifications We Need You to Possess
Bachelor's degree, preferably in an engineering or scientific discipline. 5+ years of experience manufacturing finished medical devices or in a related industry. Working knowledge of FDA QSR, ISO 13485, ISO 14971, and EU Medical Device Directive. Lead auditor credentials for QSR, ISO, or EU MDR are desirable. Strong cognitive skills; ability to work on problems of diverse scope requiring data analysis. Knowledge of probability, statistical quality control, design of experiments; Minitab proficiency preferred. Knowledge of 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. Qualifications We Would Like You to Possess
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 GD&T and gage design tolerance preferred. Benefits and Other Information Base pay range: $130,000.00/yr - $154,000.00/yr. 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. For US-Based Candidates Only We offer a comprehensive benefits package including health and wellness benefits, 401(k) with employer match, disability coverage, life insurance, paid time off, paid parental leave, paid holidays, and more. Additional compensation may include annual bonus, RSUs, and other incentives where applicable. Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We put the patient first and are committed to revolutionizing treatment for BPH through innovation in surgical robotics. We strive to improve the quality of life for patients and support surgeons, shareholders, and our employees with ongoing career opportunities. 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 as defined by law. Work Environment We provide training for compliance with PROCEPT BioRobotics Quality Management System and require adherence to Quality & EHS policies. This position also includes an annual bonus and other compensation components where applicable. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance, Supply Chain, and Manufacturing Industries: Medical Equipment Manufacturing, Transportation/Logistics, Supply Chain and Storage, and Manufacturing
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Is this the role you are looking for If so read on for more details, and make sure to apply today. This role is with PROCEPT BioRobotics, focused on revolutionizing treatment for benign prostatic hyperplasia (BPH) through surgical robotics, with a patient-first focus and opportunities for career growth. What Your Day-To-Day Will Involve
Conduct supplier assessments and audits to evaluate capabilities, processes, and quality management systems to meet Procept and regulatory requirements. Assist in selecting and qualifying new suppliers based on established procedures. Develop periodic supplier performance reports (scorecards) and establish periodic reviews with suppliers on performance and improvement plans. 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 for continuous improvement. Lead resolution of supplier-related non-conformances using problem-solving tools (8D, Fishbone, 5 WHY’s, etc.). Demonstrate in-depth understanding of manufacturing processes, including machining, fabrication, casting, injection molding, and assembly processes. Assess the quality impact of supplier manufacturing changes and deviations. Provide technical oversight for issue/problem resolution activities with strong problem-solving abilities. Understand TMV’s, process and product validations (IQ, OQ, PQ) and independently execute supplier process validation. Apply advanced quality tools (SPC, FMEA, MSA, DOE, and Quality Systems). Support continuous product and process improvement through failure analysis for nonconformances and development of corrective/preventive actions. Collaborate with R&N, Procurement, Manufacturing, and Regulatory Affairs on supplier-related initiatives. Support New Product Introduction with supplier readiness and capability assessments. Qualifications We Need You to Possess
Bachelor's degree, preferably in an engineering or scientific discipline. 5+ years of experience manufacturing finished medical devices or in a related industry. Working knowledge of FDA QSR, ISO 13485, ISO 14971, and EU Medical Device Directive. Lead auditor credentials for QSR, ISO, or EU MDR are desirable. Strong cognitive skills; ability to work on problems of diverse scope requiring data analysis. Knowledge of probability, statistical quality control, design of experiments; Minitab proficiency preferred. Knowledge of 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. Qualifications We Would Like You to Possess
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 GD&T and gage design tolerance preferred. Benefits and Other Information Base pay range: $130,000.00/yr - $154,000.00/yr. 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. For US-Based Candidates Only We offer a comprehensive benefits package including health and wellness benefits, 401(k) with employer match, disability coverage, life insurance, paid time off, paid parental leave, paid holidays, and more. Additional compensation may include annual bonus, RSUs, and other incentives where applicable. Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We put the patient first and are committed to revolutionizing treatment for BPH through innovation in surgical robotics. We strive to improve the quality of life for patients and support surgeons, shareholders, and our employees with ongoing career opportunities. 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 as defined by law. Work Environment We provide training for compliance with PROCEPT BioRobotics Quality Management System and require adherence to Quality & EHS policies. This position also includes an annual bonus and other compensation components where applicable. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance, Supply Chain, and Manufacturing Industries: Medical Equipment Manufacturing, Transportation/Logistics, Supply Chain and Storage, and Manufacturing
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