The Opportunity That Awaits You:

Do you want to be part of an innovative, cutting-edge technology and robotics company that is transforming the treatment of BPH? Are you excited to work with an enthusiastic, driven, and collaborative team that continuously learns and improves together? Are you passionate about driving process excellence and making a meaningful impact? Are you detail-oriented and thrive in a fast-paced NPI environment?

At PROCEPT BioRobotics, you will contribute to our continuous improvement culture as a member of the Quality Engineering team, supporting New Product Introduction (NPI) activities for disposables and accessories. As a Senior Quality Assurance Technician, you will perform inspections, testing, documentation, and other quality-related activities to help ensure that single-use products and accessory components meet established requirements from development through commercialization.

This role will support product quality activities with a primary focus on Verification & Validation (V&V) testing and New Product Introduction (NPI). This role works cross-functionally with R&D, Manufacturing, and Quality Engineering to ensure products meet design requirements, regulatory standards, and company quality objectives throughout the product lifecycle. Success in this position requires strong attention to detail, a hands-on and proactive approach, effective communication, and the ability to manage multiple priorities in a fast-paced NPI environment.

Key Responsibilities

• Partner with Quality Engineering, R&D, and Manufacturing during product development and design transfer to support prototype builds, design iterations, engineering studies, pilot builds, and product testing.
• Prepare, label, track, store, and maintain traceability of test samples throughout testing.
• Set up test fixtures, equipment, instrumentation, and samples in accordance with approved procedures and protocols.
• Verify that test and measurement equipment is within calibration before use and report any equipment-related issues.
• Execute design verification and validation protocols, including functional, reliability, performance, and simulated-use testing.
• Perform visual, dimensional, and functional inspections using approved methods and inspection equipment.
• Accurately record test conditions, observations, and results in accordance with Good Documentation Practices (GDP).
• Compile and summarize test data for review by Quality Engineering and other project stakeholders. Identify, document, and promptly escalate protocol deviations, nonconformances, equipment issues, and unexpected test results.
• Support failure investigations and root cause analysis by reproducing failures, collecting evidence, performing measurements, and documenting observations.
• Provide practical feedback regarding product testability, manufacturability, inspection methods, and potential quality risks.
• Support the development and improvement of test fixtures, inspection methods, work instructions, and test procedures.
• Assist with document control activities, including drafting, reviewing, and updating procedures, test methods, forms, and associated quality records.
• Support equipment maintenance, laboratory organization, material inventory, and workplace cleanliness. Follow applicable environmental, health, and safety requirements when handling equipment, chemicals, and test samples.
• Perform assigned activities in accordance with the FDA Quality Management System Regulation (QMSR), ISO 13485, EU MDR, and PROCEPT's internal quality system requirements.
• Complete required training and maintain qualification to perform assigned inspections and testing activities.
• Support multiple projects, communicate status and issues proactively, and manage assigned priorities in a fast-paced NPI environment.

The Qualifications We Need you to Possess:

• High school diploma or GED. Four or more years of experience in product testing, engineering laboratory support, or manufacturing within a regulated or technically controlled environment. An equivalent combination of education and relevant experience may be considered.
• Experience following written procedures, test protocols, work instructions, and inspection methods.
• Experience accurately documenting test results and maintaining records in accordance with Good Documentation Practices (GDP).
• Hands-on experience using basic inspection and measurement equipment, such as calipers, micrometers, force gauges, multimeters, or similar instruments.
• Basic proficiency with Microsoft Office applications, including Excel, Word, and Outlook.

The Qualifications We Want you to Possess:

• Associate degree or technical certification in engineering technology, quality, manufacturing, electronics, mechanical technology, or a related discipline.
• Experience in the medical-device, pharmaceutical, biotechnology, aerospace, or another regulated industry.
• Experience supporting design verification and validation testing, engineering studies, prototype builds, or product failure investigations.
• Familiarity with FDA quality system requirements, ISO 13485, nonconformance documentation, and document-control practices.
• Experience reading engineering drawings, specifications, bills of materials, and test methods.
• Experience working with single-use medical devices, electromechanical products, or accessory components.

Pay Range for this role:
$38.73 to $45.56