This person will ensure development of medical products in compliance with domestic and international regulations and internal procedures and policies.

• Hire, retain and lead a high-performance team that supports the shared services aspects of quality assurance, specifically:
• Supplier Quality Engineering
• Product Compliance (RoHS, REACH, WEEE conflict minerals etc.)
• Incoming Quality Control
• Equipment Calibration & Metrology
• Data Trending & Analysis
• Complaints Failure Analysis
• Shared Services will serve the needs for both business units – Capital equipment, and Disposables & Accessories
• Technical leader and mentor for the team
• Establish and build relationships with internal and external partners to support strategic business initiatives
• Lead quality personnel in the completion of required departmental activities including objectives/ goal
• Be able to lead, execute, and implement various improvement projects
• Manage quality budgeting, including planning and managing to establish targets and plans
• 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 & EHS policies

SUPERVISORY RESPONSIBILITIES

• Directly supervises employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and disciplining employees; addressing complaints and resolving problems.

• 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.
• College Degree required, B.S. in Engineering, M.S. preferred
• Experience working in medical device companies and is intimately familiar with ISO13485 and/or FDA QSR
• 7+ years of relevant experience in medical devices industry with 5 years in leadership roles
• Experience in managing the following standards/regulations:
• ISO 13485 Medical Devices – Quality Management System
• US FDA CFR21Part820 (QSR)
• ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
• Medical Device Directive (93/42/EEC – MDD)
• EU Medical Device Regulation
• SOR/98-282 Canadian Medical Device Regulations
• MDSAP
• Computer Skills: proficient in Microsoft Office tools
• Ability to work as part of a multi-disciplinary team in a small, faced paced company
• Ability to balance hands-on detailed design tasks and project management/planning functions
• Strong ability to problem solve and lead teams in root cause analysis
• Established history of taking projects from beginning to end and achieving the desired results
• Experience with electronic QMS helpful
• Experience working with electronic, software, and/or imaging devices is desirable
• Experience in understanding complex data and analyzing that data to drive the right decisions

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 25 pounds.
• While performing the duties of this job, the employee regularly works in an office environment.