Senior Quality Engineer — QMS Innovator & Compliance Leader

ClinLab Solutions Group; Houston (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A clinical-stage medical device company is seeking a Senior Quality Engineer to enhance their Quality Management System (QMS). The role involves implementing processes related to quality standards and regulatory compliance while supporting product design control activities. The ideal candidate will possess over 4 years of experience in Quality Engineering within the medical device industry and should be proficient in FDA regulations and ISO standards. Strong analytical, problem-solving, and organizational skills are essential. This is an opportunity to uphold a culture of quality in a dynamic work environment.

Qualifications

• 4+ years of Quality Engineering experience in the medical device industry.
• Knowledge of FDA regulations and ISO standards for medical devices.
• Strong problem-solving abilities.

Responsibilities

• Implement and streamline QMS processes including NCRs and CAPAs.
• Participate in Design Control activities to ensure product standards.
• Revise Risk Management profiles and documentation as required.
• Conduct audits and ensure compliance with regulatory standards.
• Support nonconformance investigations and root cause analysis.

Skills

Quality Engineering experience

Analytical skills

Problem-solving skills

Organizational skills

Communication skills

Teamwork skills

Tools

Microsoft Office (Excel, Word, Outlook)

Job description

A clinical-stage medical device company is seeking a Senior Quality Engineer to enhance their Quality Management System (QMS). The role involves implementing processes related to quality standards and regulatory compliance while supporting product design control activities. The ideal candidate will possess over 4 years of experience in Quality Engineering within the medical device industry and should be proficient in FDA regulations and ISO standards. Strong analytical, problem-solving, and organizational skills are essential. This is an opportunity to uphold a culture of quality in a dynamic work environment.