Quality Control Inspector II

CORE RESPONSIBILITIES

• Perform In-process and final inspection of disposables and capital equipment to ensure product quality
• Perform Device History Record reviews to ensure compliance with GDP
• Assist with nonconformance investigations
• Perform Incoming inspections per drawings or specifications as required
• Maintain Incoming inspection files according to PROCEPT’s procedures
• Train employees to core competencies as required
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications, and maintaining personal networks.
• Understands and adheres to the PROCEPT BioRobotics Quality and EHS policies

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.
• 3+ years of industry experience
• Basic knowledge of ISO13485:2016
• Experience using measurement instruments – calipers, micrometers, vision equipment, microscopes, flow meters, and other equipment.
• Ability to interpret CAD drawings
• Ability to work with minimal supervision
• Ability to read, comprehend, and write simple instructions, short correspondence, and memos
• Ability to effectively present information in one-on-one and small group situations
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

PHYSICAL DEMANDS

• 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 within the facility. Although not an essential duty of the position, the employee may occasionally lift and/or move up to 15 pounds.

WORK ENVIRONMENT

• While performing the duties of this job, the employee is primarily working in a cleanroom environment. The employee will then occasionally be exposed to clean room and its 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.