Job Details

The Opportunity

Atraverse Medical is an innovative, medical device start-up developing flexible left-heart access technologies to streamline procedures and improve patient outcomes. We are currently looking for a Quality Engineer to join our team!

What you will do

Develop, implement and maintain procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyze nonconforming product/process/material issues. Provides guidance and training to Quality personnel and employees of the company regarding the Quality System. Receive, analyze and respond to customer complaints. Analyze complaint patterns and categories to develop strategies for company wide improvements. Participates in Quality planning- facilities and products: requirements, documentation and completion (overview/monitoring). Project planning/product manufacture development.

Responsibilities

• Develop and update quality procedures for QMS as well as new products/processes.
• Assist in the development of new inspection and test methods.
• Provide feedback to QA, Operations and R&D on quality issues.
• Assist product development team members in initiating document changes.
• Perform gap analysis of external standards (e.g. ISO 13485)
• Develop comprehensive Risk Assessment file for new products.
• Lead supplier audits based on risk management process.
• Create and/or review quality and regulatory documents including protocols, reports, test, methods, inspection methods, design dossier, submissions, and procedures.
• Submit mandatory reports to external agencies (ex. MDR, vigilance)
• Perform risk management activities including development and maintenance of risk files in accordance with ISO 14971.
• Plan, document (protocol and reporting) product/process validations.
• Performs internal quality system audit planning, execution, reporting (including development and completion of corrective action plans).
• Initiate and maintain supplier qualification activities including supplier audits.
• Initiate and/or verify corrective and preventative actions resulting from NCMR's, audit findings and/or customer complaints.
• Develop and complete qualifications for new or changed materials and processes.
• Develop and publish UDIs.

Required Qualifications

• Bachelor's Degree in engineering related field or equivalent.
• Minimum 1-2 years in quality engineering for medical device manufacturing.
• Experienced with implementing FDA and ISO procedures resulting in facility inspection approval

Skills and Experience

• Familiarity with inspection and testing techniques
• Understanding technical documentation including mechanical drawings.
• Strong written and oral communication.
• Good intra-personal skills.
• Knowledge of Quality Systems for medical device manufacturing
• Understanding of 21 CFR 820, 21 CFR 803 and ISO 13485:2016 requirements
• Ability to identify/evaluate quality inspection/test equipment requirements.
• Ability to lead quality circles for process improvement/problem solving.
• Ability to use of video inspection equipment (desirable) and other inspection tools.
• Participate in and/or lead design review meetings.

Why should you join?

More than 1 million catheter-based procedures are performed worldwide in the left atrium of the heart each year. The ability to precisely locate the crossing site, safely traverse the septum, and deliver effective therapy is more important than ever. At Atraverse Medical, you will have the opportunity to observe this cutting-edge technology, while working as part of a highly diverse, motivated, and experienced team.

Additional Information

• ***Must live within commuting distance to Solana Beach, CA
• While performing the duties of this position, you will be required to stay in a stationary position and work on a computer for significant periods of time.
• Atraverse Medical offers Health, Dental, and Vision benefits to all full-time employees.
• Atraverse Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.