Quality Control Technician- II ( Capital Equipment ) - PROCEPT BioRobotics
San Jose, CA 95101
About the Job
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 Control Technician II will serve as the liaison between the Quality, Operations, Manufacturing, and R&D teams and will be responsible for the maintenance and execution of the equipment management and product release process. Additionally, the Quality Technician will be involved in additional quality system areas such as incoming and in-process inspections, RGA process, and supporting data acquisition and communication activities.
The ideal candidate must possess high attention to detail, have strong interpersonal and communication skills, and the ability to prioritize tasks. The candidate must establish and maintain a professional working relationship with the Quality, Operations, Manufacturing, and R&D teams.
What Your Day-To-Day Will Involve:
- Represent Quality in Capital Equipment Production and Service Operations
- Assist in and/or perform final review of manufacturing DHR (Device History Records)
- Perform labelling and packaging inspection for CE, Warehouse, and Service Production
- Compile and archive completed and approved DHR
- Compile and archive completed and approved incoming inspections records as required.
- Identify, record, and trend product or documentation quality issues as required
- Perform transactions in the ERP system to quarantine or release product and finished goods inventory.
- Issue nonconformance reports as necessary and work with Quality, Operations, Manufacturing, and R&D on resolution.
- Assist on nonconformance material movement and ERP transaction as required.
- Work may involve processing Product Return or RGA (Returned Goods) transactions
- Assist on equipment labeling related to preventative maintenance and calibration
- Audits inspection processes, equipment, and provides feedback for continuous improvement.
- Assists with engineering studies and measurement systems analysis as required.
- Assists with In-process inspections as required.
- Takes part in cross-functional and functional projects related to Product Release
- May train inspectors on new processes and procedures.
- 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 and EHS Policies
The Qualifications We Need You to Possess
- High School Diploma or equivalent, technical training, or equivalent experience.
- 2- 4 years of related experience in the Medical Device Industry or other highly regulated industry
- Experience performing DHR audits
- Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements
- Ability to work within a team and as an individual contributor in fast-paced environment
- Ability to work with minimal supervision
- Strong organizational and follow up skills as well as high attention to detail
- Solid understanding of MS Office applications
The Qualifications We Would Like You to Possess
- Process and Labelling inspection experince
- Understand GMP and GDP
For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role, the anticipated base pay range is $31 an hour -38 an hour
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.
PI249620227
Source : PROCEPT BioRobotics
