Quality Systems Specialist

Job Description

Job Description

The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the company’s Quality Management System (QMS) within an electronics manufacturing environment. This position ensures that quality processes, documentation, corrective actions, audits, and compliance activities are effectively implemented and maintained in accordance with applicable quality standards, customer requirements, and company procedures.

The Quality Systems Specialist works cross-functionally with Quality, Engineering, Manufacturing, Supply Chain, Warehouse, and other departments to promote compliance, identify opportunities for improvement, and ensure consistent execution of quality-system requirements throughout the organization.

Key Responsibilities

Quality Management System

• Maintain and support the company's Quality Management System in accordance with ISO 9001 and applicable customer, regulatory, and industry requirements.
• Develop, review, revise, and maintain quality policies, procedures, work instructions, forms, and records.
• Ensure controlled documents are current, properly approved, distributed, and maintained according to document-control requirements.
• Monitor QMS processes and identify opportunities to improve effectiveness, compliance, and efficiency.
• Assist with implementation of new or revised quality standards and customer-specific requirements.
• Support quality objectives, metrics, and management-review activities.

Corrective and Preventive Action

• Coordinate and track Corrective and Preventive Actions (CAPAs), Corrective Action Requests (CARs), and nonconformance activities.
• Facilitate root-cause investigations using appropriate problem-solving methodologies such as 5 Whys, Fishbone/Ishikawa analysis, and 8D.
• Work with process owners to develop appropriate containment, corrective, and preventive actions.
• Monitor corrective actions through completion and verify effectiveness.
• Analyze recurring quality issues and recommend systemic improvements.

Internal and External Audits

• Develop and maintain the internal quality audit schedule.
• Conduct or coordinate internal audits of departments, processes, procedures, and manufacturing operations.
• Document audit findings and communicate deficiencies to responsible process owners.
• Track audit corrective actions through closure.
• Support external certification, surveillance, customer, and supplier audits.
• Assist departments in preparing documentation and evidence for external audits.
• Maintain audit records and monitor trends in audit findings.

Nonconformance and Quality Improvement

• Support the management and disposition of nonconforming materials and products.
• Assist with Nonconformance Reports (NCRs), Material Review Board (MRB) activities, and related quality documentation.
• Analyze quality data to identify recurring defects, process weaknesses, and systemic quality concerns.
• Partner with Manufacturing and Engineering teams on continuous-improvement initiatives.
• Participate in problem-solving activities related to SMT, PCBA, assembly, box-build, inspection, testing, and other manufacturing processes.

Document and Record Control

• Maintain the document-control system for quality-system documentation.
• Coordinate document creation, review, approval, revision, distribution, and obsolescence.
• Ensure appropriate retention and protection of quality records.
• Periodically review documentation to ensure alignment with current processes and quality-system requirements.
• Assist departments with creating and revising procedures and work instructions.

Training and Compliance

• Support QMS and quality-procedure training for employees.
• Maintain or assist with quality-related training records and competency documentation.
• Communicate changes to quality policies, procedures, and requirements to affected employees.
• Promote awareness of quality requirements throughout the organization.
• Assist departments in maintaining compliance with established procedures.

Quality Metrics and Reporting

• Collect, analyze, and report quality-system performance metrics.
• Monitor trends involving corrective actions, audit findings, nonconformances, customer complaints, supplier issues, and other quality indicators.
• Prepare quality reports and presentations for management review.
• Identify adverse trends and recommend corrective or improvement actions.
• Assist Quality leadership with establishing and monitoring departmental KPIs.

Customer and Supplier Quality Support

• Assist with customer quality inquiries, corrective-action requests, and quality-system documentation.
• Support supplier corrective-action activities when required.
• Assist with reviewing supplier quality documentation and quality-system compliance.
• Support customer-specific quality requirements and documentation.
• Participate in cross-functional investigations involving customer or supplier quality concerns.

Qualifications

• Experience: 3–5 years of Quality Assurance, Quality Systems, or related experience in a manufacturing environment preferred. Electronics manufacturing, SMT, PCBA, semiconductor, automotive electronics, telecommunications experience; ISO 9001-certified Quality Management System experience; and internal auditing, corrective actions, document control, and root-cause analysis experience preferred.
• Education: Bachelor’s degree in Quality, Engineering, Manufacturing, Business preferred, or equivalent experience.
• Technical Skills:
  • Strong working knowledge of ISO 9001 and Quality Management System principles.
  • Knowledge of CAPA, NCR, CAR, MRB, root-cause analysis, and continuous-improvement methodologies.
  • Understanding of manufacturing quality processes and production environments.
  • Ability to interpret quality procedures, specifications, standards, and customer requirements.
  • Proficiency with Microsoft Office, particularly Excel, Word, PowerPoint, and Outlook.
  • Experience with ERP, MES, QMS, or electronic document-control systems preferred.
  • Certified Quality Auditor (CQA), Certified Quality Improvement Associate (CQIA), Certified Quality Engineer (CQE), or similar ASQ certification.
  • ISO 9001 Internal Auditor or Lead Auditor training.
  • Experience with IPC-A-610 and/or J-STD-001 requirements.
• Soft Skills:
  • Strong analytical and problem-solving skills.
  • Excellent written documentation and technical-writing skills.
  • Strong organizational skills with the ability to manage multiple open actions and deadlines.
  • Ability to analyze quality data and communicate findings clearly.
  • Ability to communicate effectively with production employees, engineers, managers, customers, suppliers, and auditors.
• Other: Bilingual English/Mandarin a plus.