Continuous Improvement Quality Engineer

KEY ACCOUNTABILITIES: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.)

• Provide technical leadership without direct supervisory authority unless assigned.
• Own assigned validation, investigation, and improvement deliverables
• Verify that implemented controls work effectively in production.

KEY RESPONSIBILITIES: (The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.)

• Maintain an active floor presence; partner with operators, inspectors, Operations, Engineering, and Tooling to troubleshoot defects, contain issues, and prevent recurrence.
• Develop and execute risk-based IQ/OQ/PQ protocols and reports; define sampling and acceptance criteria, investigate deviations, and assess changes for revalidation requirements.
• Lead assigned quality deliverables for new products, tooling, transfers, and changes, including specification reviews, first article inspections, and customer-required APQP/PPAP submissions.
• Lead customer complaints, RMAs, nonconformances, and CAPAs through containment, verified root cause, corrective action, effectiveness verification, and timely closure.
• Use quality data and Lean Six Sigma methods to prioritize and lead improvements in first-pass yield, scrap, rework, repeat defects, and cost of poor quality.
• Develop and maintain PFMEAs, control plans, inspection instructions, and standardized work; implement error-proofing and train affected teams across applicable shifts.
• Apply MSA/Gage R&R, SPC, capability studies, and other statistical methods to improve measurement reliability and process performance.
• Interpret drawings, GD&T, and customer requirements; support inspection methods, metrology, sampling, and product disposition within delegated authority.
• Support ISO 13485/ISO 9001 compliance, applicable regulatory requirements, audits, and controlled documentation; ensure changes preserve traceability and the validated state

LMA RESPONSIBILITIES: (Leadership, Management, Accountability) N/A

QUALITIES FOR SUCCESS: (Seaway Core Values, Education, Training, Certifications, Years of experience, Other skills and abilities, Physical Requirements for the Role, etc.)

• Demonstrates Seaway Plastics Core Values
  • We are customer focused
  • We execute
  • We win together
  • We are respectful

• Bachelor’s degree in engineering or technical discipline, or equivalent education and experience; minimum two years of manufacturing quality engineering experience.
• Working knowledge of injection molding, assembly, IQ/OQ/PQ, structured problem solving, GD&T, metrology, and statistical quality methods.
• Ability to lead cross-functional improvements, communicate with customers, write technical reports, and coach production teams; proficiency with Excel and statistical analysis software.
• Preferred: medical-device or cleanroom experience, ISO 13485/GMP knowledge, Lean Six Sigma certification, ASQ CQE, and APQP/PPAP experience.
• Ability to walk and stand for extended periods while conducting inspections, audits, and production floor evaluations.
• Frequent movement throughout manufacturing and warehouse areas, including climbing stairs and accessing equipment.
• Ability to lift and carry materials, tools, or inspection equipment up to 25 pounds.
• Manual dexterity to operate measuring instruments, testing equipment, and computer systems.
• Visual acuity to inspect products, read technical drawings, identify defects, and review quality documentation.
• Ability to bend, reach, stoop, and kneel when evaluating equipment, processes, or products.
• Capability to work in a manufacturing environment with exposure to noise, moving machinery, varying temperatures, and required personal protective equipment (PPE).
• Ability to communicate effectively with employees, suppliers, and customers in person, by phone, and electronically.