Quality Assurance Specialist
About The Position
OxyGo is seeking a detail-oriented and analytical Quality Assurance Specialist to join its Quality team in Orlando, Florida. This early-career role is suited to someone with an engineering or science background who wants hands-on experience in medical-device quality assurance. Working closely with the Quality & Regulatory Compliance Manager, the Specialist will support the Quality Management System (QMS), contribute to continuous improvement, and help maintain compliance with applicable regulatory requirements. On-the-job training and mentoring will help the Specialist build technical knowledge and progressively take ownership of assigned quality processes and projects. The role includes supporting quality documentation and processes, complaint handling, audits, training records, inspections, CAPA, supplier quality, and non-conformance management. The Specialist will also develop an understanding of product functionality, intended use, and how quality issues are investigated and resolved. OxyGo provides hands-on training in its QMS, product functionality, complaint handling, document control, internal auditing, CAPA, change control, and applicable regulatory requirements. The position offers the opportunity to develop technical expertise and take on increasing responsibility over time.
Requirements
- 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 and problem-solving abilities.
- Excellent attention to detail.
- Good organizational skills and the ability to manage documentation and follow-up activities.
- Proficiency in Microsoft Office applications.
Nice To Haves
- Basic familiarity with Good Manufacturing Practice (GMP) requirements.
- Experience with medical-device quality systems or ISO 13485.
- Experience in medical, pharmaceutical, biotechnology, laboratory, or other regulated manufacturing environments.
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 Corrective and Preventive Action (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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
