Medical Device Quality Assurance Associate

OxyGo LLC; Orlando (FL); On-site; USD 52,000 - 78,000; Full time

Job summary

OxyGo is seeking a detail-oriented Quality Assurance Specialist to join our Orlando, Florida-based Quality team. This early-career role offers hands-on experience with the QMS, regulatory compliance, and continuous improvement initiatives.

You will support procedures, investigations, audits, CAPA, supplier evaluations, and training records while collaborating across departments to ensure product quality and compliance.

Qualifications

• Associate or bachelor's degree in Engineering, Chemistry, Biology, Life Sciences, or a related field.
• 0-3 years of experience in quality assurance, quality systems, manufacturing quality, or another regulated industry.
• Strong written communication and technical documentation skills.
• Analytical thinking, problem-solving abilities, and excellent attention to detail.
• Good organizational skills and the ability to manage documentation and follow-up activities.
• Proficiency in Microsoft Office applications.

Responsibilities

• Support the development, maintenance, and improvement of quality procedures, forms, and records.
• Assist with customer complaint intake, reportability evaluations, and investigation documentation.
• Support change control activities, including implementation tracking and effectiveness checks.
• Maintain employee training records and training matrices.
• Conduct internal audits and document findings, observations, and follow-up activities.
• Assist with external audit and inspection preparation by gathering and reviewing quality documentation.
• Review incoming inspection, manufacturing, and final product testing records for accuracy, completeness, and traceability.
• Support CAPA activities, including documentation, action tracking, and effectiveness reviews.
• Assist with supplier qualification, periodic supplier evaluations, and supplier corrective action requests.
• Document and track non-conformances and deviations.
• Collaborate with Quality and other departments to identify opportunities for continuous improvement.
• Develop an understanding of product functionality, intended use, and how quality issues are investigated and resolved.

Skills

Analytical thinking

Documentation skills

Attention to detail

Organizational skills

Microsoft Office

Education

Associate or bachelor’s degree in Engineering or Life Sciences

Job description

OxyGo is seeking a detail-oriented Quality Assurance Specialist to join our Orlando, Florida-based Quality team. This early-career role offers hands-on experience with the QMS, regulatory compliance, and continuous improvement initiatives.

You will support procedures, investigations, audits, CAPA, supplier evaluations, and training records while collaborating across departments to ensure product quality and compliance.