Quality Control Technician- II ( Capital Equipment )

Company OverviewEmbark 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:   
The Senior Quality Control Technician I will serve as the liaison between the Quality, Operations, Manufacturing, and R&D teams and will be responsible for the maintenance and execution of the equipment management and product release process. Additionally, the Quality Technician will be involved in additional quality system areas such as incoming and in-process inspections, RGA process, and supporting data acquisition and communication activities. 
The ideal candidate must possess high attention to detail, have strong interpersonal and communication skills, and the ability to prioritize tasks. The candidate must establish and maintain a professional working relationship with the Quality, Operations, Manufacturing, and R&D teams.

What Your Day-To-Day Will Involve:

• Represent Quality in Capital Equipment Production and Service Operations
• Assist in and/or perform final review of manufacturing DHR (Device History Records)
• Perform labelling and packaging inspection for CE, Warehouse, and Service Production
• Compile and archive completed and approved DHR
• Compile and archive completed and approved incoming inspections records as required.
• Identify, record, and trend product or documentation quality issues as required
• Perform transactions in the ERP system to quarantine or release product and finished goods inventory. 
• Issue nonconformance reports as necessary and work with Quality, Operations, Manufacturing, and R&D on resolution. 
• Assist on nonconformance material movement and ERP transaction as required.
• Work may involve processing Product Return or RGA (Returned Goods) transactions
• Assist on equipment labeling related to preventative maintenance and calibration 
• Audits inspection processes, equipment, and provides feedback for continuous improvement.  
• Assists with engineering studies and measurement systems analysis as required. 
• Assists with In-process inspections as required. 
• Takes part in cross-functional and functional projects related to Product Release
• May train inspectors on new processes and procedures. 
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
• Understand and adhere to the PROCEPT BioRobotics Quality and EHS Policies

The Qualifications We Need You to Possess

• High School Diploma or equivalent, technical training, or equivalent experience. 
• 2- 4 years of related experience in the Medical Device Industry or other highly regulated industry 
• Experience performing DHR audits  
• Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements  
• Ability to work within a team and as an individual contributor in fast-paced environment 
• Ability to work with minimal supervision
• Strong organizational and follow up skills as well as high attention to detail 
• Solid understanding of MS Office applications 

The Qualifications We Would Like You to Possess

• Process and Labelling inspection experince
• Understand GMP and GDP

For US-Based Candidates OnlyWork Authorization Status: Citizen / Permanent Resident For this role, the anticipated base pay range is $31 an hour -38 an hourPlus, eligibility for an annual bonus and equity/RSUs.
Understanding PROCEPT's CultureAt 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-pac