Quality Engineer
On-siteConcord, North Carolina, United States
Concord, North Carolina, United StatesOn-siteFull TimeHEALTHCARELarge
Full TimeLargeHEALTHCARE
Job Summary
Support new product development and sustaining activities by managing projects from inception through launch, applying root cause analysis, FMEAs, and validation tools to ensure regulatory compliance. Lead continuous improvement initiatives by analyzing process control, waste rates, and customer complaints to drive Lean and Six Sigma solutions. Approve protocols and reports for all validation and change control activities while maintaining alignment with corporate quality policies and 21CFR820 standards. Collaborate with operations, suppliers, and quality management to monitor in-process inspection and reject rates.
Required Qualifications
- B.S. degree in Engineering (Industrial, Mechanic) or similar
- 3+ Years Quality experience including Validation and Quality Engineering responsibilities
- Demonstrate success with statistical and problem-solving methodologies
- Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices
- Strong understanding of failure analysis, test methods and engineering tolerances
- Strong verbal, written and interpersonal skills
- Proficient with Minitab or other statistical software, MS Word, Excel, and MS project
- Working knowledge of 21CFR820, ISO 13485
- Project Management experience
Desired Qualifications
- Certified Quality Engineer and Certified Quality Auditor (preferred)
- Six Sigma Certification Desired
- ASQ CQE
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