Senior Quality Assurance (QA) Technician

The QA Technician will play a crucial role in supporting our quality systems with responsibilities including complaint handling and failure investigation, performing equipment calibration and preventive maintenance, and assisting in various quality control and assurance activities. This on-site position ensures that our products meet regulatory standards and customer expectations.

Roles & Responsibilities | What you'll do:

1. Conduct Complaint Investigations and Failure Analysis

• Receive, document, and investigate returned complaint materials, including medical device pumps, to determine failure modes.
• Perform root cause analysis and document findings in detailed investigation reports.
• Develop, update, and maintain work instructions for failure analysis of various failure modes.
• Communicate investigation results and collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).

2. Perform Equipment Calibration and Maintenance

• Verify that all measurement and testing equipment is functional, appropriate for its intended use, and within calibration date.
• Maintain calibration records and schedule routine calibration and preventive maintenance activities.
• Set up and operate test equipment and testing apparatus to ensure quality and regulatory compliance.
• Identify and troubleshoot equipment issues to minimize downtime and ensure operational efficiency.

3. Inspect Incoming Materials and Components

• Conduct inspections of incoming raw materials, components, and finished products to ensure compliance with specifications.
• Use precision measuring tools such as micrometers, calipers, and gauges to verify product dimensions and tolerances.
• Document inspection results, identify non-conforming materials, and collaborate with the quality team to determine appropriate actions.

4. Ensure Compliance with Quality Management System

• Follow established quality procedures and regulatory requirements, including FDA 21 CFR Part 820 (QSR) and ISO 13485:2016.
• Participate in internal and external audits by preparing documentation, responding to auditor inquiries, and assisting with corrective actions.
• Maintain quality records, including work instructions, inspection logs, and investigation reports, ensuring proper documentation practices.

5. Support Continuous Improvement Initiatives

• Assist in process changes and new product development by providing quality input and technical support.
• Identify opportunities for process improvements to enhance product reliability, efficiency, and compliance.
• Work closely with engineering, manufacturing, and regulatory teams to support initiatives that drive continuous improvement. 

Experience | What you'll bring:

• Technical certificate or Associate’s degree in a relevant field preferred.
• 5-8 years of experience in Quality Assurance, preferably in a medical device manufacturing environment.
• Experience with FDA QSR regulations and ISO 13485 quality systems preferred.
• Familiarity with ASME Y14.5M-2009 Dimensioning and Tolerancing
• Proficiency in MS Access, Excel, Word, and ERP systems.
• Strong organizational skills with attention to detail and accuracy.
• Ability to work independently as well as cross-functionally with engineering, manufacturing, and regulatory teams.
• Physical abilities:
  • Ability to sit, stand, and walk for extended periods in a manufacturing environment.
  • Ability to lift up to 20 lbs occasionally.
  • Visual acuity sufficient for detailed inspections and working with microscopes

The salary range for this position is $110,00-$120,000.