Quality Assurance Engineer - Manufacturing - Old Lyme, CT Michael Page USA
Old Lyme, CT24 days ago
- $90,000–$115,000 Per Year
- Full-time
BN Associates Inc
- NULL, CT
- 2 days ago
- $100,000–$120,000
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Skills
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cost Controlunmatched
- Cross-Functionalunmatched
- Healthcare Qualityunmatched
- Industrial Engineeringunmatched
- Leadershipunmatched
- Lean Manufacturingunmatched
- Lean Six Sigmaunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Costunmatched
- Manufacturing Engineeringunmatched
- Manufacturing Operationsunmatched
- Manufacturing/Industrial Processesunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Operational Improvementunmatched
- Problem Solving Skillsunmatched
- Process Developmentunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Improvementunmatched
- Process Validationunmatched
- Product Supportunmatched
- Project Executionunmatched
- Project/Program Managementunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality System Requirements (QSR)unmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Root Cause Analysisunmatched
- Safety Complianceunmatched
- Technical Leadershipunmatched
Description
Sr. Quality Engineer
North Haven, CT (Onsite)
Job Description & Skill Requirement:
- Provide technical leadership and daily manufacturing support for multiple product families within manufacturing operations.
- Responsible for maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements.
- Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement initiatives.
- Support process validation activities, manufacturing process development, equipment improvements, and operational excellence projects.
- Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required. Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.
Qualification:
- Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related Engineering discipline.
- 7+ years of Experience in manufacturing engineering within medical devices or other regulated industries.
- Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
- Experience with root cause investigations, process improvements, and cross-functional project execution.
- Lean Manufacturing and Six Sigma experience preferred.
Numbers & Facts
| Location | NULL, CT |
| Salary | $100,000–$120,000 |
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