Quality Engineer

Venova Medical, Inc.; Los Gatos (CA); On-site; USD 135,000 - 165,000; Full time

Job summary

Venova Medical, Inc. is seeking a Quality Engineer to own QA activities for a high-risk Class III medical device under clinical trials.

You will ensure compliance with FDA QMSR, ISO 13485/14971, and related regulations, partnering with R&D, Operations and Clinical Affairs to release safe and effective devices. Responsibilities include maintaining the quality system, conducting data analysis, leading CAPA and investigations, and supporting supplier qualification and document control in a

Qualifications

• BS Engineering with 4+ years in medical device or related environment.
• Familiar with FDA 21 CFR Part 820 QMSR, ISO 13485, and ISO 14971.
• Experience with precision measurement tools and basic statistical sampling.

Responsibilities

• Support quality operations to ensure compliance with regulations; provide training on quality awareness.
• Contribute to quality initiatives to ensure effectiveness of the quality management system; data analysis and audits.
• Perform document control tasks and ensure timely release of documents and change orders.
• Lead root-cause investigations and CAPA activities with a risk-based approach.
• Qualify suppliers and monitor performance to meet requirements; support product/process changes.

Skills

Quality principles

Data analysis

Root cause analysis

Communication

Team collaboration

Statistical sampling

Education

BS Engineering

Job description

Company Description

Venova Medical, Inc. is focused on improving hemodialysis outcomes by advancing vascular access solutions for patients in the United States. The company is developing next-generation vascular access systems designed to overcome both patient-level and system-level barriers to access creation. These solutions aim to enable rapidly functioning arteriovenous fistulas with fewer reinterventions, lower healthcare costs, and improved patient experiences. Venova Medical operates in a mission-driven environment where innovation and quality directly impact patient care and clinical efficiency.

Position Title:

Quality Engineer

Department:

RA/QA

Reports to:

Quality Assurance Manager

FLSA Status:

Exempt

PURPOST OF THE JOB:

The Quality Engineer will own and drive quality assurance activities tailored to a high-risk Class III medical device navigating clinical trials. Responsible for performing a wide variety of activities pertaining to quality assurance.Assure compliance with applicable regulatory requirements and company policies by closely working with R&D, Operations, Clinical Affairs to ensure release of safe and effective device. Support and lead Quality objectives by planning, managing, implementing and ensuring continued compliance with the quality system.

MAJOR DUTIES AND RESPONSIBILITIES:

• Support quality operations to ensure continued compliance with applicable regulations/standards and provide the necessary training to ensure awareness of personnel
• Contribute to quality initiatives and functions to ensure effectiveness of the quality management system, including but not limited to, product and process monitoring, data analysis and applying statistical techniques, audit support, purchasing and verification, control of equipment, etc.
• Perform quality functions such as procedure writing, inspection, testing and reviewing documents, lot history records, inspection records for accuracy and application of procedures or standards
• Assess opportunities for improvement and need for changes to the quality system by systematically monitoring and reviewing data pertaining to the organization, product or process changes, non‑conforming product, changes to regulations/standards, complaints and feedback
• Perform gap assessment of external standards/regulations as needed.
• Coordinate and/or assist with Document Control activities such as supporting the entire process of initial release of documents and subsequent change process in accordance with established SOPs. Follows up on open Document Change Orders (DCOs) to ensure timely completion.
• Own and/or support activities pertaining to complaint handling, vigilance and medical device incident reporting to ensure compliance with the applicable regulations. Work cross functionally to help identify root cause and any necessary corrective actions.
• Qualify suppliers and monitor supplier performance to ensure product meets specified requirements
• Lead investigations, root cause analysis, and determination of required action to be taken in response to non‑conforming product or process (NCMR) using a risk based approach
• Own, drive and/or participate in CAPA process
• Assist in the development of dFMEAs (Design Failure Mode Effect Analysis) and pFMEAs (Process Failure Mode Effect Analysis) and control plans where required.
• Maintain traceability, identification, documentation and applicable records to provide evidence of product and processes meeting requirements
• Solve multidisciplinary engineering problems at the component through system level.
• Conduct testing utilizing existing test protocols or develop new ones as needed.
• Ensure adherence to FDA Quality Management System Regulation (QMSR) standards across the product lifecycle—from pre‑production quality assurance and pre‑clinical testing to post‑market compliance,in close collaboration with Document Control, Clinical, and Quality Assurance teams.
• Provide guidance to associate engineers and technicians on engineering/test activities.
• Designs, schedules, and if necessary, perform specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable regulatory requirements.
• Perform other duties in Quality Assurance and Regulatory Affairs as needed.

PREFERRED QUALIFICATIONS:

Education and/or Job Experience

• BS Engineering and minimum 4 years engineering experience supporting a medical device or related environment
• Working knowledge of FDA 21 CFR Part 820 QMSR, ISO 13485, and ISO 14971 (risk management) is highly desirable.
• Experience with precision measurement tools and basic statistical sampling methods.

Skills, Abilities, and Requirements

• Solid understanding of quality principles and methodologies
• Solid data analysis and data interpretation skills
• Identify and resolve quality issues independently
• Strong communication, presentation and team collaboration.
• Staying updated with evolving standards, tools and technologies

PAY RANGE:

The expected annual salary range for this role is $135K-$165K. Actual compensation will be determined based on a variety of factors, including experience, qualifications, skills, location, and internal equity.