Quality Control Technician - San Jose

CORE RESPONSIBILITIES

• Audit product Device History Records (DHR) to release final product for shipment to sterilizers.
• Manages communication with sterilization supplier and audits sterilization certificates.
• Identify, record, and trend product or documentation quality issues.
• Perform transactions in the ERP system to quarantine or release product to sterilization and finished goods inventory.
• Issue nonconformance reports as necessary and work with quality engineers on resolution.
• Communicate with internal departments to ensure timely execution of preventive maintenance and calibration activities.
• Coordinate calibrations with external suppliers.
• Maintain calibration system including database.
• Maintain preventive maintenance system.
• Track and report equipment metrics.
• Audits inspection processes, equipment, and provides feedback for continuous improvement.
• Assists with engineering studies and measurement systems analysis as required.
• Assists with Incoming and In-process inspections as required.
• 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 EHS policy

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• High School Diploma or equivalent, technical training, or equivalent experience.
• Minimum of 5 years of related experience in the Medical Device Industry or other highly regulated industry
• Experience managing equipment calibrations
• Experience performing DHR audits
• Experience managaning calibration and preventive maintenance systems
• Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements
• Ability to interpret CAD drawings
• Familiarity with inspection equipment (CMM, Vision Systems, calipers, gages, etc.)
• Ability to work within a team and as an individual contributor in fast-paced environment
• Strong organizational and follow up skills as well as high attention to detail
• Solid understanding of MS Office applications

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee may occasionally lift and/or move up to up to 15 pounds.
• The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
• While performing the duties of this job, the employee is regularly working in a warehouse and clean room environment.