Quality Assurance Specialist

OxyGo LLC; Orlando (FL); Presencial; USD 52.000 - 78.000; Tempo integral

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Analytical thinking

Documentation skills

Attention to detail

Organizational skills

Microsoft Office

Formação

Associate or bachelor’s degree in Engineering or Life Sciences

Descrição da vaga

OxyGo is seeking a detail-oriented and analytical Quality Assurance Specialist to join our Quality team in Orlando, Florida. This is an excellent opportunity for an early-career professional with a background in engineering or the sciences to gain hands-on experience in medical-device quality assurance.

Working closely with the Quality & Regulatory Compliance Manager, you will support our Quality Management System (QMS), contribute to continuous improvement initiatives, and help maintain compliance with applicable regulatory requirements. Through on-the-job training and mentoring, you will develop your technical knowledge and progressively take ownership of assigned quality processes and projects.

What You'll Do

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.

What We're Looking For

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.

Preferred Qualifications:

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.

Prior medical-device experience is not required. We are prepared to provide training to the right candidate.

Training and Career Development

You will receive hands-on training in OxyGo's Quality Management System, product functionality, complaint handling, document control, internal auditing, CAPA, change control, and applicable regulatory requirements. You will have the opportunity to build valuable technical expertise, develop your quality assurance skills, and take on increasing responsibility over time.

Why Join OxyGo?

Join a team where attention to detail, continuous improvement, and product quality make a difference. This position offers an opportunity to develop your career in a specialized field while contributing to the quality and reliability of medical-device products.

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