Quality Engineer - CI

Seaway Plastics•Port Richey, FL

20h

About The Position

The Quality Engineer provides hands-on quality engineering support focused on continuous improvement for injection molding and assembly, from new-product introduction and process validation through ongoing production. The role maintains a regular production-floor presence to resolve quality issues at their source, strengthen process controls, and lead measurable improvements in product quality, process capability, scrap, and rework. The position leads quality and improvement work across functions, supports new products and process changes, and ensures compliance with quality, customer, and regulatory requirements. It provides technical leadership without direct supervisory authority unless assigned, and owns assigned validation, investigation, and improvement deliverables while verifying that implemented controls work effectively in production.

Requirements

Demonstrates Seaway Plastics Core Values: customer focused, execute, win together, and respectful.
Bachelor’s degree in engineering or a 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.

Nice To Haves

Medical-device or cleanroom experience.
Knowledge of ISO 13485/GMP.
Lean Six Sigma certification.
ASQ CQE.
APQP/PPAP experience.

Responsibilities

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.
Maintain an active production-floor presence and 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.
Provide technical leadership without direct supervisory authority unless assigned; own assigned validation, investigation, and improvement deliverables and verify implemented controls work effectively in production.