Quality Assurance Engineer
On-site · Middletown, New Jersey, United States
Job Summary
Quality Engineer at Datwyler responsible for ensuring product, process, and quality system compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and customer requirements. Supports manufacturing and NPI through risk management, process validation (IQ/OQ/PQ), PFMEA, CAPA, and root cause analysis. Drives continuous improvement using Lean and Six Sigma, participates in supplier and customer quality activities, audits, and validation documentation, and ensures timely quality deliverables for project milestones. Works on quality planning for new products/transfers, reviews customer specifications and validation requirements, and collaborates with customers to resolve quality issues.
Required Qualifications
- Bachelor’s degree in Engineering, Quality, Science, or a related discipline
- 2–5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging
- Experience with molding or precision manufacturing processes preferred
- Strong knowledge of ISO 13485, FDA 21 CFR 820, Risk management (ISO 14971), Process validation, Experience with statistical tools and SPC
- Proficiency in MS Office; experience with eQMS systems is a plus
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