Quality Assurance

Benefits:

• medical
• dental insurance
• vision care
• 401k plan
• paid time off

Responsibilities

• Support the development, maintenance, and continuous improvement of quality systems within a regulated medical device environment.
• This role will be responsible for ensuring compliance with FDA Quality Management System Regulations (QMSR), ISO 13485, and EU Medical Device Regulation (MDR) requirements.
• Maintain and improve the Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, and EU MDR requirements.
• Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.
• Review and approve quality system documentation, including procedures, work instructions, specifications, and records.
• Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.
• Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.
• Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation.

3+ years of experience in Quality Management within a medical device manufacturing environment. The ideal candidate will have experience supporting medical device products, including software-enabled devices, and a strong understanding of quality and regulatory requirements throughout the product lifecycle.