Address
Form of workPROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company's AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.
SUMMARY
This is a full time role with the Failure Analysis team in the QA, PMS and QMS team. The Quality Technician II - Failure Analysis is responsible for managing the Return Good Authorization (RGA) process to assure prompt disposition and analysis of our products.
CORE RESPONSIBILITIES- Responsible for daily processing of Return Goods Authorization (RGA), including receipt and decontamination of returned product, and track down and follow-up on RGAs pending return
- Organize and Maintain the Decontamination and Failure Analysis Lab
- Assist with sending investigated complaint devices to external storage
- Perform specific product testing/Failure Analysis of customer returned products using standard physical, mechanical, and/or electrical measurements
- Assist in providing complaint devices to other cross functional teams and logging the request.
- Assist the Failure Analysis team with ad hoc requests and projects to meet team goals.
- Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends
- Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support with regulatory compliance
- Train in other aspects of the complaint handling process to ensure regulatory compliance and assist the overall PMS team
- Understand and adhere to the PROCEPT BioRobotics Quality and EHS policies; adhere to Good Manufacturing Practices and Good Documentation Practices
- May perform other duties, as assigned
- Maintain documentation related to the Failure Analysis investigation process in accordance with SOPs, WIs, etc.
- Perform review of appropriate quality records such as Device History Records (DHR), Non-Conforming Products Reports (NCMR), Corrective Action/Prevention Action (CAPA), etc.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 2+ years of medical device industry experience, preferably working experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements
- 2+ experience in decontamination of medical devices and return goods authorization process preferred
- Ability to read and comprehend complex instructions, correspondence, and memos
- Demonstrates ability to perform detail-oriented work with a high degree of accuracy
- Ability to work with cross functional teams like Receiving to appropriately receive and decontaminate complaint devices
- Proficient with Microsoft Office tools including, Word, Excel, PowerPoint, and Outlook
- Ability to work proactively and with minimal supervision in a fast-paced environment
- Ability to multitask and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic and growing company
- Ability to effectively present information in one-on-one and small group situations to team members and other cross functional groups
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to follow processes and improve them to meet higher demand
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Effective written and oral communication skills and critical thinking skills
- Effective time management and interpersonal skills
- Experience in use of measurement instruments/tools
- 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 within the facility.
- Although not an essential duty of the position, the employee may occasionally lift and/or move up to 50 pounds.
- While performing the duties of this job, the employee is regularly working in an office environment/ lab.
- The employee is frequently required to work in the warehouse
For US Based Candidates Only
For this role, the anticipated base pay range is $62,000-$86,000 a year.
PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.
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