Senior Quality Engineer
On-siteRochester, New York, United States
Job Summary
Manage and support complaints and CAPAs using root-cause analysis tools like 5-why and Fishbone analysis. Lead major quality system improvement projects, document continuous improvement activities, and trace production history through ERP systems. Serve as a Subject Matter Expert for document control, change control, training, and validation while supporting internal and external audits. Perform supplier audits, qualify new suppliers, and lead process audits. Write and revise forms, work instructions, and SOPs, manage change orders, and train others on process changes. Support engineering development, validation activities, and communicate directly with customers throughout project meetings.
Required Qualifications
- Bachelor's degree in engineering, Quality, Manufacturing, or related technical discipline
- 8 years of Quality Engineering experience in a regulated manufacturing environment
- ASQ Certified Quality Engineer (CQE)
- Lean Six Sigma Black Belt certification
- Proficient with statistical software
- Ability to travel as required to Suppliers, Customers, and other events
- Up to 10%
- Must be able to lift up to 15 pounds at times
- Visual acuity for inspections, color differentiation, reading electronic documentation
- Strong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality System
- Excellent verbal and written communication skills
- Excellent interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Strong leadership skills
- Ability to prioritize tasks and to delegate them when appropriate
- Ability to function well in a high-paced and at times stressful environment
- Ability to simplify complex situations and present them with an appropriate level of detail
- Ability to analyze risk and make decisions
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