Description

You will maintain Quality Management Systems for medical devices and combination products, focusing on remediation and continuous improvement.

Responsibilities

• Maintain Medical Device and Combination Products Quality Management Systems through remediation and continual improvement.
• Develop and monitor Quality and Regulatory Compliance strategies for manufacturing site activities.
• Provide SME support during regulatory and customer audits to address auditor concerns.
• Author, review, and approve GMP-related SOPs and documentation.
• Support technical execution of Design History File (DHF) enhancements and updates.

Required Skills

• 5+ years of experience in Quality Engineering or Quality Assurance roles.
• 5+ years of experience in Medical Device or Combination Products Quality, Design Controls, or Production.
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820 and Part 4).
• Proficiency with ISO 13485:2016 and ISO 14971 requirements and standards.
• Experience with GMP, SOPs, and internal/external audit support.
• Bachelor's degree in Chemistry, Biochemistry, Engineering, Life Science, or a related technical/scientific field.

Key Skills

Education

Any Graduate