Senior Supplier Quality Engineer

PROCEPT BioRobotics•San Jose, CA

About The Position

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.

Requirements

Bachelor's degree preferably in engineering or scientific discipline.
5+ years’ experience working in manufacturing finished medical device or related industry.
Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, and the EU Medical Device Directive.
Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.
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.

Nice To Haves

Lead auditor credentials for QSR, ISO, or MD SAP, and EU MDR 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.

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.
Oversee compliance with Environmental Regulations, including WEEE, Battery Directive, REACH, RoHS, and Conflict minerals compliance.