Quality Systems Coordinator

About the Role

The Quality Systems Specialist is responsible for maintaining, improving, and ensuring the effectiveness of the Quality Management System (QMS) on a site focused on Research & Development. The role drives compliance with ISO 9001 requirements throughout the electronics product development lifecycle, including contract manufacturing, by ensuring that documented processes are implemented, monitored, and continually improved. This position promotes a quality-focused culture that enables the development of innovative, reliable, and manufacturable electronic products while meeting customer, regulatory, and business requirements. This role is a remote-hybrid position with up to 50% travel.

Responsibilities

• Quality Management System
  • Maintain and continuously improve the ISO 9001 Quality Management System.
  • Develop, review, and maintain quality procedures, work instructions, templates, and process documentation.
  • Support Management Review by preparing quality performance reports and improvement recommendations.
• Design and Development Support
  • Ensure quality requirements are integrated throughout the product development lifecycle, including:
    • Design planning, inputs, reviews, verification, validation, changes, and outputs.
    • Support lessons learned and knowledge capture following development projects.
• Document and Configuration Control
  • Maintain controlled procedures, specifications, standards, design templates, and quality records.
  • Ensure document revisions are properly reviewed, approved, distributed, and archived.
  • Support engineering change management processes and document change control activities.
• Internal Auditing and Compliance
  • Plan, coordinate, and conduct internal audits.
  • Coordinate external certification audits and customer quality audits.
  • Track audit findings through to effective closure.
• Corrective and Preventive Actions
  • Coordinate the CAPA process.
  • Facilitate root cause investigations using structured problem-solving techniques such as 5 Why, Fishbone Diagram (ISHIKAWA), A3, and FMEA.
  • Verify effectiveness of implemented corrective actions.
  • Monitor recurring issues and identify systemic improvement opportunities.
• Risk-Based Thinking
  • Promote risk-based thinking throughout product development activities.
  • Encourage preventive actions through proactive process improvement.
• Training and Quality Culture
  • Deliver training on Quality Management System processes and ISO 9001 requirements.
  • Support onboarding of new engineering staff regarding quality procedures.
  • Promote awareness of quality objectives and customer requirements throughout R&D.
  • Encourage best practices in documentation, traceability, and process discipline.

Requirements

• Education: Bachelor's degree in Engineering, Electronics, or a related technical discipline.
• Experience:
  • 3–5 years' experience in Quality Systems, Quality Assurance, or Engineering within an electronics or technology development environment.
  • Experience maintaining an ISO 9001 certified Quality Management System.
  • Experience supporting engineering or product development teams.
  • Internal auditing experience preferred.
• Knowledge:
  • ISO 9001:2015 Quality Management Systems
  • Electronics product development lifecycle
  • Engineering change management
  • Document control
  • Root cause analysis
  • Continuous improvement methodologies
  • Process mapping and process optimization

  Knowledge of the following is advantageous:

  • IPC standards
  • IEC standards applicable to electronic products
  • Product lifecycle management (PLM) systems
  • Electronic document management systems (eQMS)

Skills

• Strong understanding of Quality Management Systems.
• Excellent organizational and documentation skills.
• Strong analytical and problem-solving capability.
• Ability to communicate effectively with engineering and technical teams.
• Experience facilitating cross-functional meetings and process improvements.
• Ability to interpret standards and translate requirements into practical processes.
• Strong attention to detail.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office and quality management software.

Preferred Certifications

• ISO 9001 Lead Auditor or Internal Auditor
• ASQ Certified Quality Auditor (CQA)
• ASQ Certified Quality Engineer (CQE)
• Lean Six Sigma Green Belt

Pay

Applicants can expect a base compensation range of $88,000 - $118,000, plus benefits and additional incentives based on the level of the role.

Benefits

• Health, dental, and vision insurance
• Long-term and short-term disability
• Life insurance
• HSA/FSA options
• Matching retirement plans
• Paid vacation
• Parental leave
• Employee stock purchase plan
• Paid leave for volunteer work in your community
• Training opportunities
• Professional talent management and succession planning
• Corporate health and well-being initiatives
• Commitment to diversity, equity, inclusion, and sustainability