Quality Systems Engineer

Jeron Electronic Systems, Inc./Provider®Nurse Call; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Jeron Electronic Systems, Inc./Provider®Nurse Call in the United States is seeking a Quality Systems Engineer to develop, implement, and maintain the QMS in compliance with 21 CFR Part 820, ISO 13485, and global regulations. You will ensure quality processes are audit-ready and support product development and manufacturing.

You will lead CAPA, change control, document control, and supplier quality activities, conduct internal audits, and serve as the expert during inspections, driving continuous

Qualifications

• 5+ years in the medical device or regulated industry.
• Strong working knowledge of applicable FDA regulations.

Responsibilities

• Maintain and continuously improve the QMS in accordance with 21 CFR Part 820, ISO 13485, and global regulations.
• Own and manage key QMS processes: CAPA, nonconformance & deviation management, change control, document control & records management.
• Lead internal audits and support external audits (FDA).
• Act as 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.

Skills

QMS ownership

Audit experience

Design controls & risk management

Problem-solving

Communication & collaboration

Education

Bachelor’s degree in engineering, Life Sciences, or related field

Job description

The Quality Systems Engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS) in compliance with applicable medical device regulations and standards. This role ensures that quality processes are effective, audit-ready, and support both product development and manufacturing.

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