Continuous Improvement Quality Engineer
BS-level Quality / Testing roles on Crosslinked list a median of $108k (199 that show pay). This posting does not list pay.
Drive quality improvement and process validation (IQ/OQ/PQ) for injection molded products, leading CAPAs, SPC and defect reduction.
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Worth knowing
Why it is interesting. Hands-on IQ/OQ/PQ validation and CAPA leadership on injection molded products, with ISO 13485 exposure
Might not be for you. Quality-systems and compliance heavy, with little materials R&D or formulation work
Adjacent materials roleQuality engineer at an injection molding plant: "Working knowledge of injection molding, assembly, IQ/OQ/PQ"; leads process validation, defect reduction and SPC on molded products
- Seniority
- Mid-level
- Work
- On-site
- Type
- Full-time
- Degree
- BS
- Experience
- 2+ yrs
- Industry
- Medical devices
- Role
- Quality / Testing
Role details
Join our innovative plastics manufacturing team as a Continuous Improvement Quality Engineer, where you'll play a key role in driving continuous improvement, reducing defects, and enhancing product quality across our operations. This hands-on position partners closely with production, engineering, and quality teams to analyze processes, implement corrective actions, and lead initiatives that improve efficiency, customer satisfaction, and overall manufacturing performance. If you're passionate about problem-solving, data-driven decision-making, and creating lasting operational improvements, we'd love to hear from you.
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.
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