Quality Technician at Velentium Medical – Houston, Texas

The Quality Technician supports the Quality Assurance (QA) and Quality Control (QC) functions to ensure compliance with FDA, ISO, and other applicable regulatory standards. This role is responsible for performing inspections, testing, documentation, and process monitoring to maintain product quality and support continuous improvement.

DUTIES AND RESPONSIBILITIES:

Inspection & Testing

• Perform incoming, in-process, and final inspections on components, subassemblies, and finished devices.
• Creates inspection reports based on drawings and component specifications.
• Utilize precision measurement tools (calipers, micrometers, gauges) to verify product conformance to specifications.
• Conduct functional and visual testing in accordance with established procedures and standards

Documentation & Reporting

• Accurately document inspection results and maintain device history records (DHRs).
• Identify, document, and escalate nonconformances in accordance with company procedures.
• Support preparation of quality reports, trending data, and metrics for management review.

Regulatory & Quality System Compliance

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements.
• Assist in internal audits, supplier audits, and regulatory inspections.
• Participate in Corrective and Preventive Action (CAPA) investigations by providing data and inspection support.

Nonconforming Product

• Coordinates identification and control of nonconforming product and the associated documentation.
• Provides nonconforming material to engineering for further investigation as needed.

Supplier Management

• Follows up with Suppliers to obtain necessary quality documents such as surveys, certificates and supplier agreements.

Continuous Improvement

• Provide feedback on inspection and testing processes to improve efficiency and effectiveness.
• Assist engineering and manufacturing teams with root cause analysis and problem-solving activities.
• Support validation activities, calibration, and verification of inspection equipment.

QUALIFICATIONS

Basic Qualifications:

• Associate’s degree in Quality, Life Sciences, or related field; equivalent work experience may be considered.
• 3 years of quality experience in a regulated medical device or related industry.
• Familiarity with FDA QSR, ISO 13485, and ISO 14971 standards.
• Strong attention to detail and ability to follow standard operating procedures (SOPs).
• Experience with measurement tools, inspection equipment, and statistical sampling plans.
• Proficient in Microsoft Office and quality management systems (QMS software preferred).
• Strong communication and teamwork skills.

Additional Qualifications:

• Highly adaptable and flexible to meet the needs of the Quality organization and business
• Ability to prioritize and plan activities
• Resolves most issues with peers, but understands what issues are important to escalate to management
• A fit with Velentium Medical culture: Honor, Results++, Humble Charisma, Velocity, Ingenuity
• Demonstrated experience that displays an ability to learn and apply new skills
• A demonstrated ability to work alone and in teams
• A desire to thrive in a rapidly changing and quick paced environment
• An attitude of doing whatever it takes to figure out the solution to challenging problems

WORKING CONDITIONS

Activities will be performed under office conditions or on a manufacturing floor. Physical requirements include:

• Prolonged periods sitting at a desk and working on a computer
• Must be able to occasionally lift up to 15 pounds
• Primarily on-site in a manufacturing and cleanroom environment.
• May require use of personal protective equipment (PPE).
• Occasional overtime or weekend work may be required to support production schedules.