Quality Engineer

Quality Engineer - Lansing, MI

GENERAL PURPOSE:

The Quality Engineer is responsible for ensuring product quality, compliance, and operational excellence throughout the product lifecycle. This role supports change control activities, validation programs, product stewardship initiatives, and continuous improvement efforts by applying quality systems, risk-based decision making, and data-driven analysis. The Quality Engineer collaborates cross-functionally to assess and implement changes, develop and execute validation strategies, monitor product and process performance, investigate quality issues, and drive sustainable improvements based on key performance metrics. Through proactive quality oversight and continuous monitoring, this position helps maintain regulatory compliance, product reliability, customer satisfaction, and overall business performance in the Lansing plant.

ESSENTIAL JOB FUNCTIONS:

• Lead and execute validation activities for new and existing products, processes, equipment, and software systems.
• Develop validation protocols, plans, reports, and documentation including IQ, OQ, and PQ activities as applicable.
• Ensure validation activities are completed in compliance with customer requirements and internal standards.
• Collaborate with Operations and Engineering to assess process capability and establish process controls.
• Maintain validation records and ensure ongoing compliance with established procedures.
• Administer and maintain the site Change Control process.
• Evaluate proposed changes for potential impact on product quality, regulatory compliance, production efficiency, and customer requirements.
• Coordinate cross-functional reviews and approvals for change requests.
• Ensure validation, risk assessments, and implementation activities are completed prior to change approval.
• Track change control actions through closure and verify effectiveness of implemented changes.
• Serve as Product Stewardship representative
• Maintain compliance with applicable environmental, health, safety, and product regulatory requirements.
• Manage raw material, product, and supplier compliance documentation.
• Review product formulations, specifications, and changes to ensure continued regulatory compliance.
• Coordinate customer requests related to product compliance, certifications, declarations, and material disclosures.
• Utilize quality tools such as SPC, FMEA, Control Plans, 5 Whys, Fishbone Diagrams, and Pareto Analysis to improve processes.
• Lead quality improvement projects focused on reducing defects, waste, and variability.
• Support Lean Manufacturing and continuous improvement initiatives.
• Develop and report quality performance metrics to management.

QUALIFICATIONS:

• Must have an Associate’s degree in a related field and 2 years Quality experience, or a combination of training, experience.
• Certified Quality Engineer certificate is preferred.
• Familiarity with ISO 9001 is preferred.
• Must have the ability to read and write complex instructions, correspondence and memos.
• Must have the ability to respond to customer inquiries, complaints, regulatory agencies.
• Must be comfortable with effectively presenting information to top management and public groups.
• Must have good mathematical skills, especially knowledge and skill in statistics.
• Must be competent in Excel, Powerpoint, and Outlook products.
• Must be able to perform all essential functions of the job with or without reasonable accommodation.