Failure Investigation Technician - Pleasanton, CA

Calyxo • Pleasanton, CA

8d • $36 - $43 • Onsite

About The Position

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary:
The Failure Investigation Technician receives complaint devices for investigation, investigates customer complaints, facilitates investigations, generates complaint investigation reports, and ensures completeness and consistency of the complaint files and records documentation. This position requires experience with FDA Quality Management System Regulations and the ability to perform at high levels in a high-paced, dynamic environment.

Requirements

• Education: Bachelor’s degree in Science, Engineering or another technical field is a plus; High School diploma or equivalent required.
• At least 4 years of relevant experience with medical device investigations and complaints, or equivalent experience in a related field.
• Work location: Pleasanton
• Travel: up to 5% travel
• Full time employment
• Experience with ISO13485, MDD, and FDA Quality Management System Regulations is preferred.
• Technical writing, analytical, critical-thinking, and interpersonal communication skills.
• Experience handling biohazards materials preferred.
• Proficient in Microsoft Word, Excel, and Outlook.
• Proficiency with measurement tools (calipers, micrometers) and diagnostic equipment (microscopes)
• Responsible for performing all duties in compliance with FDA’s Quality Management System Regulation (QMSR), ISO13485, and all other international regulatory requirements with which Calyxo complies.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables.
• Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.
• Requires regular presence in a (clinical or engineering or animal) laboratory setting where protective equipment or other health and safety measures and training are required to protect against chemical, biological or other hazards. Noise levels may be high.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
• Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Nice To Haves

• Experience with ISO13485, MDD, and FDA Quality Management System Regulations is preferred.
• Experience handling biohazards materials preferred.
• Experience with Propel (electronic quality management system) software a plus.

Responsibilities

• Receive, Log, and Label Incoming Complaints devices to prepare them for investigation
• Maintain proper handling and storage of returned products to prevent further damage.
• Address and correct Incoming Complaint device discrepancies by coordinating with relevant departments
• Perform decontamination on returned Complaint devices as needed in accordance with company procedures which includes safely cleaning and handling biohazardous materials and ensuring proper disposal of contaminated waste/devices.
• Perform detailed visual, dimensional, and functional inspections using specialized tools and equipment
• Conduct and record timely investigation of returned products through troubleshooting and testing to determine root cause of reported failure mode.
• Partner with Product Complaint Engineering team to analyze test results to demonstrate root cause failures and linkage to customer reported symptoms.
• Escalate complaints when encountering new failure modes and partner with Engineering, Field Personnel, and Quality Assurance to investigate.
• Perform Lot History Review (LHR) and record results when necessary.
• Summarize investigation and analysis results in and submit for appropriate approvals.
• Communicate potential trends associated with product complaint data to Quality.
• Maintain sufficient and accurate technical records per company policy.
• Verify calibration of tools and verify the laboratory equipment is functioning properly.
• Maintain the investigation area in a clean, organized, and compliant state.
• Monitor and replenish inventory of lab supplies (e.g., gowns, gloves, cleaning materials, tools) to ensure uninterrupted operations.
• Coordinate biowaste pickup and ensure proper disposal in compliance with safety and regulatory guidelines.
• Participate in training and development of Engineering and Laboratory personnel.
• Ensure work performed complies with FDA's Quality Management System Regulatory, ISO 13485, MDD, and all other applicable quality requirements.
• Perform other Quality System duties (e.g., CAPA, Internal Audits), as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!

Benefits

• At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.
• A competitive hourly rate of $36–$43 per hour, plus a variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 11-50 employees