MedTech Quality Engineer: Compliance & Process Excellence

NuVasive Clinical Services Monitoring, Inc.; Memphis (TN); Sur place; USD 70 000 - 95 000; Plein temps

Résumé du poste

Globus Medical is seeking a quality assurance professional to design, implement, and maintain QA protocols for materials to finished products. You will guide compliance with safety, quality, and regulatory standards for worldwide distribution and assist in reporting issues and improvements across production processes.

The role involves reviewing changes for validation, performing inspections, investigating complaints, supporting CAPA and design control activities, and contributing to quality

Qualifications

• Proficient in computer technology including MS Office applications.
• Strong attention to detail and analytical skills.
• Ability to work effectively in a team; good organizational skills.
• Experience with FDA/state regulations and ISO 13485 is preferred.
• Typically requires a bachelor’s degree and related experience.

Responsabilités

• Reviews product and process changes for qualification and validation requirements.
• Implements systems to ensure timely quality inspections for materials and finished goods.
• Conducts investigations into complaints or audit issues as quality feedback.
• Supports non-conforming material program and design control activities.
• Assists with quality initiatives and documentation for process improvements.
• Ensures compliance with FDA, state regulations, and ISO 13485 standards.

Connaissances

MS Office

Analytical skills

Teamwork

Detail oriented

Regulatory knowledge

Formation

Bachelor's degree in engineering

Description du poste

Globus Medical is seeking a quality assurance professional to design, implement, and maintain QA protocols for materials to finished products. You will guide compliance with safety, quality, and regulatory standards for worldwide distribution and assist in reporting issues and improvements across production processes.

The role involves reviewing changes for validation, performing inspections, investigating complaints, supporting CAPA and design control activities, and contributing to quality