Quality Engineer - CI

Role details

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 . 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.