Senior Supplier Quality Engineer - job 1 of 2

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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:   

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? 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 (ISO) 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.  

• 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.

• 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. 

• 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. 

For US-Based Candidates Only

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 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 doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s 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 won’t 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! 

PROCEPT’s 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 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. 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 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 to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.