Product Quality Analyst - Pharmaceutical/Medical Devices

Job Summary
The Quality Assurance/Quality Control (QA/QC) Specialist will ensure compliance with all regulatory requirements and company quality standards for our medical device self-test kits sold through nationwide retail channels and online platforms. This position is responsible for implementing and maintaining quality management systems, conducting inspections and audits, and collaborating with cross-functional teams to address quality issues. The ideal candidate will have a meticulous approach to quality control, strong knowledge of FDA regulations for medical devices, and the ability to create and maintain thorough documentation.

Responsibilities

• Implement and maintain quality management systems in compliance with FDA regulations
• Develop, review, and update Standard Operating Procedures (SOPs), Work Instructions, and quality documentation
• Coordinate with external regulatory bodies during inspections and respond to audit findings
• Maintain quality records and documentation in accordance with regulatory requirements
• Develop and implement inspection plans for incoming materials, in-process products, and finished self-test kits
• Perform quality control testing and document results according to established protocols
• Investigate out-of-specification results and implement corrective actions
• Conduct final release of products to ensure they meet all quality and regulatory requirements
• Process and investigate product complaints from retail partners, online platforms, and end-users
• Coordinate with production and engineering teams to implement corrective and preventive actions (CAPA)
• Provide quality and compliance training to staff across departments
• Stay current on FDA regulations, ISO standards, and industry best practices related to medical devices
• Perform internal audits to verify compliance with quality system requirements
• Prepare for and participate in regulatory inspections and notified body audits

Required

• Bachelor's degree in a scientific discipline, Engineering, or related field
• Minimum 3 years of experience in quality assurance/quality control for medical devices or in vitro diagnostic products
• Thorough knowledge of FDA Quality System Regulation
• Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Proficiency in quality control statistical techniques and root cause analysis methodologies
• Excellent attention to detail and documentation skills
• Strong written and verbal communication abilities

Preferred

• ASQ certification (CQA, CQE, or CQIA)
• Experience with self-test kits or point-of-care diagnostic products
• Knowledge of retail and e-commerce quality requirements for medical devices
• Familiarity with electronic quality management systems (eQMS)
• Experience preparing for and hosting FDA inspections
• Understanding of human factors and usability engineering for self-test medical devices
• Knowledge of CLIA-waived test requirements

Job Type: Full-time

Pay: $31.00 - $45.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $31 - $45