Senior Quality Systems Engineer

San Jose, CA
RAQA /
Full-Time /
Hybrid
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.

SUMMARY

Do you want to be part of an innovative, cutting edge technology, robotics 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 a leader who wants to make a difference and improve processes? At PROCEPT BioRobotics you will have an opportunity to own the Corrective and Preventive Action (CAPA) program, and work with cross-functional teams to drive effective and efficient CAPA initiation, processing, and closure. You will also contribute to ensuring compliance of the greater Quality System with the requirements of FDA's Quality System Regulation (QSR), ISO 13485, EU MDR and other applicable regulations and standards. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

CORE RESPONSIBILITIES

    • CAPA Process Owner/Subject Matter Expert.
    • Chair CAPA Review Board meetings and assure effectiveness of CAPA system.
    • Provide guidance to CAPA owners through utilizing understanding and application of quality tools, methodologies, and software (i.e., Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.
    • Monitor and track the implementation of CAPAs resulting from internal system triggers and internal and external audits (FDA, Notified Body, etc.) and report progress to management on a routine basis.
    • Lead and guide CAPA teams with members from multiple functional areas in the identification/implementation of CAPA actions and determining the effectiveness of the actions.
    • Review progress of CAPAs through defined phases to ensure compliance to process and regulations, consistency throughout Quality Management System, and thorough, complete, correct and timely documentation.
    • Establish, implement, prepare, and assess monthly metrics reports for CAPA process to assess program performance against Key Process Indicators (KPI).
    • Establish and drive strategies to achieve quality and compliance goals with regards to the CAPA investigations and the CAPA metrics program. This includes the establishment of Quality System policies and procedures as needed to ensure compliance.
    • Work closely with senior management and colleagues to ensure the CAPA department provides a responsive, efficient, and effective service to customers.

    • Quality System
    • Ensure Quality System conforms to the Quality System Regulations (QSR), ISO 13485, MDD, MDR, CMDR, PAL, other applicable regulations and standards, corporate and sector requirements.
    • Identify, lead, and implement Quality System Improvements in conjunction with Quality Management.
    • Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
    • Support external regulatory agency and internal audit activities as assigned.
    • Cross-train in the Computer System Lifecycle, State of the Art and other Quality programs as necessary.

QUALIFICATIONS

    • Completed Bachelor's degree in engineering, science or other technical area.
    • minimum of five years of Quality System experience in FDA/GMP regulated industry.
    • ASQ Certification (CQE, CQA, CMQ/OE, etc.) preferred.
    • Advanced knowledge and understanding of Quality Systems and applicable GMP regulations and standards.
    • Extensive experience with the CAPA program. Program ownership/management experience preferred.
    • Ability to effectively present information in one-on-one and group situations across all levels of the organization
    • Ability to work with mathematical concepts such as probability and statistical inference
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
    • Strong and effective time management, interpersonal and communication skills.

PHYSICAL DEMANDS & 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 15 pounds.
    • While performing the duties of this job, the employee regularly works in an office environment. 
    • COVID-I9 Vaccine Requirement: As of August 19, 2021, all PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.
For US Based Candidates Only
For this role, the anticipated base pay range is $120,000 -$166,000 a year.

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 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.
 
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.
-          You will be occasionally required to attend animal or cadaver labs and to manipulate models and/or organs for testing
-          You may frequently pack and unpack packages
-          You may occasionally lift and/or move up to up to 50 pounds.
 
WORK ENVIRONMENT
-          You will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
-          You may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
-          You will occasionally/frequently be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn.
-          While performing the duties of this job, you are regularly working in a warehouse environment.
-          You will be expected 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.
-          You will have to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies
 
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.