Director, Quality Engineering Operations, Disposables & Accessories

CORE RESPONSIBILITIES

• Overall leadership of quality engineering teams that support the Disposables & Accessories operations functions.
• Hire, retain and lead a high-performance team that supports the relevant manufacturing operations, some of which include in-process and final quality control, sustaining quality engineering, supplier quality, design transfer of new products into manufacturing
• 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
• Support Lean/Six Sigma initiatives on our manufacturing line
• Support DFX initiatives on the manufacturing line to ensure high product quality
• Drive R&D/Advanced Manufacturing Engineering to provide Manufacturing designs with high process capability
• Maintain job descriptions of subordinates. Orients new employees to the department and company
• Assure that the department maintains an awareness and practice of employee safety
• Manage and execute the overall quality engineering strategy for a particular product line or platform
• Drive comprehensive and detailed Program plans to successful completion
• Identify program risks and develop risk mitigation strategies to maintain program expectations
• Identify program problems and drive solutions such as allocation of resources or changing specifications
• Participate in formulating plans and objectives for the program area and generally review and approve projects and their implementation within the various functional areas
• Assure the successful transition to manufacturing and satisfactory field service support to customer as required.
• Travel to suppliers or contract manufacturers as needed
• 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.
• College Degree required, B.S. in Science, Engineering or equivalent combination of education and experience. M.S. preferred
• Experience working in a structured design process such as ISO13485 or FDA QSR, knowledge of regulatory approval process and requirements
• 8+ years of relevant experience in medical devices industry with 5 years in leadership roles
• Experience in managing the following standards/requirements:
• ISO 13485 Medical Devices – Quality Management System
• US FDA CFR 21 Part 820 (QSR)
• ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
• Medical Device Directive (93/42/EEC - MDD)
• EU Medical Device Regulation (EU 2017/745)
• SOR/98-282 Canadian Medical Device Regulations
• Experience working in a fast-paced, high growth environment
• Proficient in project management tools like Smartsheet
• Strong organizational skills, detail oriented. Exceptional oral and written communication skills
• Experience with Microsoft Office including Microsoft Word, PowerPoint
• Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
• Ability to balance hands-on tasks and team management/budget planning functions
• 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
• Ability to lead and collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Clinical Affairs, Marketing, Quality, etc.)
• Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams.
• Ability to work to a deadline and to handle multiple tasks simultaneously.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write and review reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, individual contributors, and customers.
• Ability to apply mathematical concepts such as multiplication, exponents, logarithms, and unit of measure conversions.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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.

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 safely within the facility. The employee may occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT

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