Quality Systems Engineer

Key Responsibilities:

• Maintain and continuously improve the Quality Management System in accordance with 21 CFR Part 820, ISO 13485, and any other applicable global regulations
• Own and manage key QMS processes, including:
  • CAPA(Corrective and Preventive Actions)
  • Nonconformance and deviation management
  • Change Control
  • Document control and records management
• Lead internal audits and support external audits (such as FDA)
• Act as a subject matter expert for quality systems during inspections and audits
• Ensure timely and compliant closure of quality events (CAPAs, complaints, etc)
• Develop and deliver training on QMS processes and quality standards
• Monitor quality metrics and drive continuous improvement initiatives
• Support supplier quality activities as needed

Qualifications:

Education and Experience:

• Bachelor’s degree in engineering, Life Sciences, or related field
• 5+ years of experience in the medical device or regulated industry
• Strong working knowledge of applicable FDA regulations

Skills and Competencies:

• Experience managing or owning QMS processes
• Strong audit experience (internal and external)
• Solid understanding of design controls and risk management
• Strong problem-solving skills
• Excellent communication and cross functional collaboration abilities