Quality Process Engineer: Validation & Process Improvement

Smurfit Westrock; Lansing (MI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary reflecting skills

401(k) match

Health Savings Account

Life insurance

Tuition reimbursement

Job summary

Smurfit Westrock in Lansing, MI seeks a Quality Process Engineer to ensure product quality, regulatory compliance, and operational excellence across the lifecycle. You will drive validation strategies, risk management, and data-driven improvements with cross-functional teams.

Responsibilities include leading IQ/OQ/PQ activities, change-control administration, and ongoing quality performance reporting. Applicants should have relevant associate-level education, quality experience, and proficiency

Qualifications

• Associate’s degree in a related field and 2 years quality experience or equivalent.
• Certified Quality Engineer preferred.
• Familiarity with ISO 9001 preferred.
• Ability to read and write complex instructions, correspondence and memos.
• Ability to respond to customer inquiries, complaints, and regulatory agencies.
• Comfort presenting information to top management and public groups.
• Strong mathematical skills with statistics knowledge.
• Proficiency in Excel, PowerPoint, and Outlook.

Responsibilities

• Lead and execute validation activities for new and existing products, processes, equipment, and software systems.
• Develop validation protocols, plans, reports, and documentation (IQ, OQ, PQ).
• Ensure validation activities meet customer requirements and internal standards.
• Collaborate with Operations and Engineering to assess process capability and establish controls.
• Maintain validation records and ensure ongoing compliance with procedures.
• Manage site Change Control process and evaluate proposed changes for impact on quality and compliance.
• Coordinate cross-functional reviews and approvals for change requests.
• Ensure validation, risk assessments, and implementation are completed prior to change approval.
• Track change control actions through closure and verify effectiveness.
• Serve as Product Stewardship representative and maintain regulatory compliance.
• Manage documentation for raw materials, products, and suppliers.
• Review formulations, specifications, and changes for compliance.
• Address customer requests related to product compliance and declarations.

Skills

Quality experience

Statistics

Excel

PowerPoint

Outlook

Reading/writing complex instructions

Education

Associate’s degree in a related field

Certified Quality Engineer

Tools

SPC

FMEA

Control Plans

5 Whys

Fishbone Diagrams

Pareto Analysis

Excel

PowerPoint

Outlook

Job description

Smurfit Westrock in Lansing, MI seeks a Quality Process Engineer to ensure product quality, regulatory compliance, and operational excellence across the lifecycle. You will drive validation strategies, risk management, and data-driven improvements with cross-functional teams.

Responsibilities include leading IQ/OQ/PQ activities, change-control administration, and ongoing quality performance reporting. Applicants should have relevant associate-level education, quality experience, and proficiency