Manufacturing Quality Systems and CAPA Engineer
Durex Manufacturing
Trout Valley, IL, United States
1 day ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Compensation
$100,000
Working hours
Regular working hours
Job source
Tech stack
Data Analysis
Systems Engineering
Failure Mode Effects Analysis
Microsoft Office
Statistical Process Control (SPC)
Job description
- Do you enjoy being the first call when a customer raises a product quality concern-and the last word on how it gets solved?
- Are you energized by running CAPAs, closing audit actions, and strengthening ISO 9001 processes?
- Can you translate SPC data, PFMEAs, and control plans into real, measurable improvements on the floor?
What You’ll Own
- Customer-facing quality: tackle escapes, uplift scorecard performance, and coordinate product/equipment qualifications.
- Quality System health: manage CAPA, complaints, and audit activities to keep the system robust.
- Continuous improvement leadership to meet customer expectations and internal targets.
- Active role in development activities: validation planning, SPC & data analysis, control plans, technical reporting, PFMEA contributions.
- Design/print reviews: highlight significant characteristics and define controls.
- Compliance ownership: ensure products conform to customer and regulatory requirements.
- Internal response leadership: organize the team for fast, clear action on quality events.
- Process optimization: introduce and validate improved procedures, QA methods, tooling, and equipment.
- Returned product analysis: verify issues, perform failure analysis, and implement corrective actions.
- Sampling strategy: devise QA sampling and associated analytics to drive improvements.
- Problem-solving facilitation: lead teams that fix issues and prevent recurrence.
- Project participation: deliver QA oversight for new and updated manufacturing processes.
- Quality advocacy: mentor peers and champion best practices.
- Primary liaison: serve as the designated quality contact for assigned customers.
- Tool mastery: apply structured problem-solving and document Corrective-Preventive Actions using the 8D approach.
- Nonconformance control: lead review/disposition with clear metrics and follow-through.
Requirements
Manufacturing Systems, Systems Engineering, Corrective and Preventative Action (CAPA) Systems, ISO 9001, Customer Relations, Scorecarding, Corrective and Preventative Action (CAPA) Systems, Systems Administration/Management, Continuous Improvement, Leadership, * Bachelor’s in Engineering (or similar technical discipline) or equivalent experience.
- 5+ years in industrial manufacturing support roles.
- Experience implementing and improving ISO 9001 and Lean practices.
- History of direct customer engagement on quality matters.
- Strong written/verbal communication, organization, and problem-solving skills.
- Detail orientation and proficiency in Microsoft Office.
Your Toolkit
- PFMEA
- APQP
- Supplier Management
- Manufacturing Instruction (MI)
- Standard Operating Procedures (SOPs)
- AS9100 Quality Systems
- Quality Control Experience
- Tolerance Analysis
- Precision Measurement & Hand Metrology
- Advanced Inspection & Gauge Measurement
- Quality Control Data Analysis
- PPAP Process Experience
Tech in Our Shop
- ERP Software
- Coordinate Measuring Machine (CMM), Must be authorized to work in the US without sponsorship, both now and in the future.
Benefits & conditions
$80,00.00 - $100,000.00 annually
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