Document Control Specialist

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You: 

Do you want to be part of an innovative, cutting-edge technology, robotic company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learns from one another? Are you looking to make a difference and learn? At PROCEPT BioRobotics you will have an opportunity to work with cross-functional teams to maintain the Document Control and Training programs within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and other applicable regulations and standards. Being detail and solution oriented and proactive will assist in the success of this position.

What Your Day-To-Day Will Involve:

• Maintain and support all company-controlled documentation as part of the Quality System including hard and soft copies; drawings, specifications, lab notebooks, Design History Files, corrective/preventative action, internal audits, Device History Record.
• Understand and demonstrate the ability to perform document control processes. Provide end-user assistance in the Engineering Change Order (ECO) processes and of the Product Lifecycle Management System.
• Analyze document changes for correctness and completeness. Ensure the correct and timely implementation of document control requests. Verify own work, check format and compliance with company templates.
• Create and maintain document templates, as needed, while ensuring continuous improvement.
• Review, and comment on current document control systems improvements and ensure their proper implementation.
• Use CAD (SolidWorks) to make simple redline changes to part drawings.
• Maintain training compliance by updating training plans.
• Work on assignments where judgment is required and making recommendations.
• Support external standards library.
• Provide support with internal and regulatory audits and inspections as required (i.e. CA, FDB, FDA and ISO).
• Scan and clean documents in preparation for electronic and offsite storage archiving. Support the offsite storage program.
• Work effectively within teams with rapidly changing priorities.
• Take and document meeting minutes.
• 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.

The Qualifications We Need You to Possess

• 3+ years of document control experience in the medical device industry or related industry
• Bachelor’s degree or equivalent combination of related education and experience required
• Knowledge and understanding of Document Control standards, practices, and principles
• Experience with databases and advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
• Basic working knowledge of CAD (SolidWorks) software
• Effective written and oral communication skills
• Effective time management and interpersonal skills
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy and the ability to multitask
• Ability to work independently as well as collaboratively in a team environment
• Ability to work proactively and effectively in a fast paced, high change environment
• Flexible; adapts work style to meet organization needs
• Demonstrated initiative and resourcefulness
• Assumes responsibility and accountability for results
• Committed to self-development and professional growth; solicits feedback from others

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $72,000-90,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

BENEFITS OF WORKING AT PROCEPT! 

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.