The Staff Quality Compliance Engineer will lead quality compliance projects, identify process risks, and implement solutions while ensuring adherence to regulations.
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and 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:
Reporting to the Senior Director, Global Quality Compliance and PMS, the Staff Quality Engineer, Quality Compliance will devise and lead execution of meaningful actions to improve the compliance, effectiveness, and efficiencies of processes within the Quality Compliance and PMS function. This role will represent Quality Compliance and PMS when partnering with internal department and cross-functional stakeholders and process owners. Develop and implement Quality tools to monitor key quality metrics that reflect health of the Quality System and identify opportunities for continuous improvement to scale workflows in support of evolving business needs.
What Your Day-to-Day Will Involve:
- Lead and manage special projects for the Quality Compliance and Post-Market Surveillance team, including planning, execution, and delivery of strategic initiatives and continuous improvement efforts.
- Proactively identify process risks and improvement opportunities within the Quality Management System (QMS), leveraging a deep understanding of cross-functional interdependencies to implement sustainable, effective solutions.
- Serve as a Quality Compliance and Post-Market Surveillance team representative on cross-functional initiatives, operating independently while influencing stakeholders and coordinating activities to meet project objectives.
- Perform and lead Corrective and Preventive Actions (CAPA), including conducting thorough root cause investigations and developing corrective actions with appropriate scope and rigor relative to the identified quality issue.
- Define key performance requirements for processes and projects; establish monitoring mechanisms and evaluate effectiveness against defined objectives to ensure continuous improvement.
- Review and interpret regulations, standards, and guidance to ensure products, processes, and services remain compliant and aligned with state-of-the-art and regulatory expectations.
- Apply sound technical judgment, data-driven analysis, and pragmatic problem-solving within the constraints of applicable regulations, standards, and internal procedures.
- Drive cross-functional collaboration by effectively engaging subject matter experts and stakeholders to achieve aligned, timely outcomes.
- Demonstrate leadership through technical competence, influence, accountability, and independent decision-making, without direct people management responsibility.
- Maintain trained status and comply with the PROCEPT BioRobotics Quality Management System (QMS) and EHS policies.
- Perform other duties as assigned.
The Qualifications We Need You to Possess:
- Bachelor’s degree in engineering, science, or another technical discipline.
- 8 years of progressive experience in a medical device industry, including at least 5 years in quality systems, quality engineering, and/or compliance roles.
- Working knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR regulatory requirements.
- Working knowledge of computer software validation principles, including in-device software, GxP systems, and 21 CFR Part 11.
- Demonstrated ability to lead project teams and deliver results within aggressive timelines.
- Strong analytical, organizational, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to clearly convey complex concepts to diverse audiences.
- Ability to apply conceptual and systems thinking to understand complex issues and downstream implications.
- Proven ability to collaborate effectively in a fast-paced, matrixed environment.
- Ability to travel up to 10% as required.
The Qualifications We Prefer You to Possess:
- Master’s degree in engineering, science, or another technical discipline.
- Prior supervisory or managerial experience.
For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role, the anticipated base pay range is $144,000-169,000 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 represents a 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.
PROCEPT BioRobotics – Applicant Privacy Notice
When you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, résumé or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.
To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].
Top Skills
21 Cfr Part 11
Computer Software Validation Principles
Eu Mdr
Fda Qsr/Qmsr
Gxp Systems
Iso 13485
Mdsap
PROCEPT BioRobotics San Jose, California, USA Office
150 Baytech Dr, San Jose, California, United States, 95134
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