Quality Systems Engineer

Jeron Electronic Systems, Inc./Provider®Nurse Call; Niles (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Jeron Electronic Systems, Inc./Provider®Nurse Call seeks a Quality Systems professional to own and continuously improve the QMS across global regulations. You will lead CAPA, change control, and document control efforts, and support audits including FDA inspections.

The role requires strong knowledge of 21 CFR Part 820, ISO 13485, and risk management, with emphasis on cross-functional collaboration and training delivery to raise quality standards across the organization.

Qualifications

• 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.

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, 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.

Skills

QMS ownership

CAPA management

Nonconformance management

Change control

Document control

Internal audits

FDA regulations

Design controls

Risk management

Problem solving

Cross-functional collaboration

Communication

Education

Bachelor's degree in engineering or life sciences

Job description

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