Quality Control Lead - San Jose

CORE RESPONSIBILITIES

• Coordinates with QC and Production Supervisor and organizes line workload and staffing depending on priorities.
• Plans, organizes, and assigns activities required to complete quality inspections per production schedule
• Host daily meetings with QC operators for better communication and continuous improvement.
• Communicates with operations lead to align on daily manufacturing and inspection goals
• Assists with production output tracking and ensures all deadlines and schedules are met.
• Track and escalate downtime.
• Responsible for training and retraining employees to assigned procedures.
• Inform or instruct employees of any deviations, reworks, or changes.
• Perform regular process and quality performance audits of personnel, tooling, and equipment in assigned areas
• Identify process and cost improvements.
• Ensures PM (preventive maintenance) and Calibration stickers are up to date.
• Notifies QC Supervisor immediately regarding all employee concerns or recommendations.
• Motivates and challenges all line members to perform to their full potential through direct and timely formal and informal feedback.
• Support Quality Control Management in tracking goals and objectives
• Participate in performance management related to QC resources
• 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 industries.
• Minimum of 3 years of experience in a lead or supervisory role.
• Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization
• Demonstrated organizational skills, attentiveness to detail, and the ability to work under minimal supervision is required
• Ability to prioritize and handle multiple tasks and deadlines daily.
• Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements
• Strong understanding of MS Office applications
• Ability to maintain regular and predictable attendance
• Occasional scheduled overtime is a requirement of this position

MANAGERIAL RESPONSIBILITIES

• This role assists the Quality Control Supervisor with the daily operations and organization of in-process and final quality control activities. This role does not have direct reports.

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.
• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.
• The employee will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
• 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 cleanroom.