Quality Engineer - CI

Provide hands-on quality engineering support focusing on continuous improvement for injection molding and assembly, from new-product introduction and process validation through ongoing production. Maintain a regular production-floor presence to resolve quality issues at the source, strengthen process controls, and lead measurable improvements in product quality, process capability, scrap, and rework.

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

• Drive continuous improvement projects to enhance quality and efficiency.
• Analyze data, identify trends, and perform root cause investigations.
• Implement and verify corrective and preventive actions (CAPA).
• Partner with cross-functional teams to optimize processes and reduce waste.
• Support Lean Six Sigma initiatives and quality objectives.
• Ensure compliance with quality, customer, and regulatory requirements.

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) 

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

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

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• 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.
• Prolonged sitting, standing, and walking throughout office and manufacturing areas.
• Occasional lifting and carrying of up to 25 pounds.
• Frequent use of computers and standard office equipment.
• Ability to observe manufacturing processes and perform facility inspections.
• Occasional bending, reaching, crouching, and climbing stairs while supporting improvement initiatives on the production floor.