Quality Systems & Compliance Engineer — Audit & CAPA Lead

Foxconn WI; Mount Pleasant (WI); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision insurance

401K with employer contribution

Paid time off

Onsite Aurora Health & Wellness Center

Career growth in smart manufacturing

Resumo da oferta

FII USA, Inc., a Foxconn Technology Group Company, is seeking a Quality Systems and Compliance Engineer to coordinate campus-wide QMS compliance and support internal audits, corrective actions, and ongoing audit readiness. You will develop risk-based audit programs and oversee CAPA governance across facilities, while assisting the Training and Development Department in a manufacturing environment.

The role requires strong knowledge of QMS, auditing, and regulatory requirements.

Qualificações

• Bachelor's degree in Quality, Engineering, Manufacturing, Operations, Business, Science, or related discipline is preferred; equivalent relevant experience may be considered.
• Three or more years of quality systems, quality engineering, compliance, internal auditing, CAPA, manufacturing quality, or related experience is required. Experience supporting customer, certification-body, or regulatory audits is preferred.
• Formal internal-auditor or lead-auditor training is strongly preferred. ASQ, ISO auditor, Six Sigma, quality engineering, or related certification is a plus.
• Strong knowledge of Quality Management Systems, internal auditing, CAPA, root-cause analysis, corrective action, risk-based thinking, and effectiveness verification.
• Working knowledge of applicable ISO-based, customer, and manufacturing quality requirements.
• Ability to conduct objective audits, gather evidence, interview personnel, identify system gaps, and write clear findings and reports.
• Strong facilitation and problem-solving skills using structured methods such as 5 Why, fishbone analysis, fault-tree thinking, or similar tools.
• Ability to analyze data and identify recurring, cross-functional, or systemic patterns rather than treating each event independently.
• Strong technical writing, procedure development, presentation, project-management, and organizational skills.
• Ability to challenge incomplete actions constructively and maintain independence while partnering effectively with process owners and leadership.
• Proficiency with Microsoft Office, audit or CAPA systems, dashboards, spreadsheets, and controlled-document platforms.
• Ability to manage multiple audits, corrective actions, deadlines, and escalations in a fast-paced manufacturing environment.

Responsabilidades

• Maintain and improve assigned QMS procedures, forms, checklists, audit tools, CAPA methods, governance controls, compliance calendars, and implementation standards aligned with company, customer, certification, and regulatory requirements.
• Develop the risk-based annual audit program across campus processes, buildings, shifts, products, and system elements.
• Plan, conduct, document, and follow up on process, system, layered, and compliance audits; coordinate scope, schedules, auditors, evidence, meetings, reports, and action deadlines.
• Administer centralized CAPA and audit-action tracking from ownership and containment through root cause, correction, verification, effectiveness, and closure.
• Facilitate structured investigations for systemic, cross-functional, repeated, or high-risk issues.
• Review corrective actions for adequacy, cause alignment, risk reduction, and sustainability.
• Verify effectiveness through audits, data, observation, sampling, recurrence analysis, or other objective evidence before closure.
• Coordinate customer, certification, regulatory, and corporate audit readiness, evidence, logistics, responses, and finding closure.
• Analyze internal and external findings, customer concerns, ESD, calibration, document control, training, production quality, and other data for system weaknesses.
• Prepare management-review inputs and dashboards covering audit performance, repeat findings, CAPA aging, overdue actions, risk, and improvement priorities.
• Support compliance readiness for new buildings, lines, processes, transfers, and significant changes.
• Guide process owners on procedures, evidence, corrective action, and audit readiness while preserving their operational ownership.
• Provide internal-auditor, CAPA, root-cause, and quality-system awareness training as assigned.
• Maintain complete, accurate, controlled records for audits, CAPAs, management review, compliance assessments, and effectiveness verification.
• Lead improvements that reduce recurring findings, simplify evidence collection, improve action closure, and standardize campus practices.
• Define coordinator checklists, sampling instructions, and evidence expectations; review their reports, confirm findings, initiate CAPAs when warranted, and direct follow-up and effectiveness checks.

Conhecimentos

Auditing

CAPA

Quality management

Data analysis

Documentation

Formação académica

Bachelor's degree in Quality, Engineering, Manufacturing, Operations, Business, Science, or related discipline

Ferramentas

Microsoft Office

Auditing/CAPA systems

Dashboards

Descrição da oferta de emprego

FII USA, Inc., a Foxconn Technology Group Company, is seeking a Quality Systems and Compliance Engineer to coordinate campus-wide QMS compliance and support internal audits, corrective actions, and ongoing audit readiness. You will develop risk-based audit programs and oversee CAPA governance across facilities, while assisting the Training and Development Department in a manufacturing environment.

The role requires strong knowledge of QMS, auditing, and regulatory requirements.