Quality Engineer

PROCEPT BioRobotics • Fulltime • San Jose, CA, USA, United States • $92k - $116k / year • 6m ago

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:

The Quality shared services team is seeking a motivated and collaborative individual to maintain the Nonconforming material report (NCMR) system per internal procedures and applicable regulations. The role would manage the overall NCMR SOPs, the NCMR system and provide periodic trend reports on key performance indicators. Under the guidance of the Sr. manager quality shared services this quality engineer will provide guidance to the NC materials coordinator on the management of nonconforming materials per the disposition determined by the cross functional Material Review Board (MRB) team including the movement of materials as needed both in the warehouse and within manufacturing areas.

What Your Day-To-Day Will Involve:

NCMR QE will help the NCMR process owner with maintaining the NCMR process in Propel, trend NCMR data, manage the overall NC workflow process, and maintain NCMR metrics data integrity.
Conduct weekly NCMR review meeting to review status of open NCMRs.
Provide NCMR trend analysis and reported during periodic management Review meetings.
As NCMR Propel Coordinator this role is responsible for supporting the NC process workflow and re-assigning NCMR approvers as required.
Assist NCMR approvers by ensuring overall information documented on the NC including supporting documents are accurate, relevant, and complete.
Support and back up to MRB Coordinator managing, labeling, and maintaining the quarantined materials as they move in and out of the MRB Cage, and performing any enterprise resource planning (ERP) transactions.

The Qualifications We Need You to Possess

Bachelor of Science in Engineering or combination of relevant education and experience .
3 – 6 years relevant experience in medical device manufacturing.
Experience in medical device manufacturing and with strong working knowledge of cGMPs.
Manufacturing or Quality Engineering experience.
Experience with Non conforming material software tools.
Experience with development and authoring procedures (SOPs, Work Instructions).
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred).
Demonstrated knowledge of Project Management principles.
Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Strong organizational skills, detail oriented. Exceptional oral and written communication skills.
Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $92,000-116,000 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.