Quality Systems 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:  

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are 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? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to work with cross-functional teams while supporting Quality System activities, such as, but not limited to, external standards program, audits, Computer System Lifecycle, and CAPAs. This position will report to the Sr. Manager of Quality Systems.

• Coordinating the External Standards program, including but not limited to, ordering standards, assigning for assessment, tracking completion of assessment and action items, maintaining library, conducting meetings, taking meeting minutes and working with cross-functional teams to ensure program is compliant.
• Coordinating/supporting internal and external audit activities, including but not limited to, updating audit plan, reserving conference rooms, preparing agenda, coordinating with Subject Matter Experts and management, scheduling preparation meetings, opening and closing meetings and tracking non-conformances to closure.
• Supporting CSV activities to ensure the organization’s Non-product Computer Software program is in compliance with applicable requirements.
• Supporting QMS process improvement initiatives.
• Reviewing quality records for correctness and completeness and tracking to closure.
• Supporting and assisting the Quality Systems Manager with projects as needed.

• Bachelor’s degree, or equivalent combination of related education and experience.
• Two to five years of Quality System experience in FDA/GMP regulated industry.
• Knowledge and understanding of external standard program management under medical device Quality Management System.
• Knowledge and experience with internal and external audits.

• Understanding of Document Control standards, practices, and principles.
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy and the ability to multitask.
• Take and document meeting minutes.
• Effective written and oral communication skills.
• Effective time management and interpersonal skills.
• 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.
• Demonstrates initiative and resourcefulness.
• Assumes responsibility and accountability for results.
• Committed to self-development and professional growth; solicits feedback from others.
• Hybrid. Three days on site, two days remote and on site as needed.

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $86,000-108,000 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.