Quality Systems and Compliance Engineer

Description

Responsibilities

• 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. Maintain objective review of compliance-team work.
• Other duties as assigned.

Qualifications

• Bachelor's degree in Quality, Engineering, Manufacturing, Operations, Business, Science, or a 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.
• Certifications and Training: 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.

Reasons you should work for us:

• Comprehensive benefits package including medical, dental, and vision insurance coverage.
• Basic life insurance and short-term disability coverage provided by employer.
• Supplemental life insurance and long-term disability coverage options available.
• 401K with employer contribution.
• Personal, Vacation, and Holiday paid time off for all full-time employees.
• Onsite Aurora Health & Wellness Center available for all employees.
• Employees are continuously encouraged to learn and grow their careers in smart manufacturing.