Senior Operations Quality Engineer - North Haven, CT
$98.4k - $147.6kMedtronic
Senior Operations Quality Engineer role supporting Advanced Surgical Instruments manufacturing at a medical device leader. Drives product quality, process performance, and compliance across stapling product families while partnering with engineering and manufacturing teams on continuous improvement initiatives.
Responsibilities
- Lead quality engineering initiatives to improve product quality, manufacturing performance, and system effectiveness
- Develop and implement inspection, testing, validation, and monitoring strategies for products and processes
- Analyze quality and production data to identify trends, investigate issues, and drive corrective actions
- Support regulatory and internal audit readiness through compliant documentation and quality system execution
- Mentor quality team members and contribute to continuous improvement projects
Requirements
- Bachelor's degree with 4+ years quality/manufacturing/engineering experience, or Master's with 2+ years, or PhD
- Experience supporting quality systems in regulated manufacturing environments
- Knowledge of Quality System Regulation, ISO 13485, or equivalent quality standards
- Process validation, test method validation, or equipment qualification experience
- Root cause investigation and corrective/preventive action implementation experience
- ASQ Certified Quality Engineer, Six Sigma certification, or related quality credential
- Unrestricted U.S. work authorization required
Vacancy posted 12 hours ago
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