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Job Requirements of Quality Validation Engineer - Plastics - CT:
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Employment Type:
Full-Time
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Location:
Torrington, CT (Onsite)
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Quality Validation Engineer - Plastics - CT
My client is looking for a Lead Quality Validation Engineer to join their growing site in Torrington. This professional will be responsible for a variety of tasks including tooling and component inspection, quality improvement, and gauging instruments. The main focus will be to assure that all products meet all customer requirements.
Client Details
My client is global manufacturer and leading provider of assembly for medical devices. They are backed by over 60+ years of excellence and have over 10 locations worldwide. Three of those locations are located in New England with the site in Torrington anticipating excellent growth over the coming year.
Description
The key responsibilities of the Quality Validation Engineer are the following:
Validation Protocol Development and Execution
- Develop and implement validation master plans, protocols, and reports for equipment, processes, and software.
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
- Ensure validation activities comply with FDA, ISO 13485, and other relevant regulatory requirements.
Risk Assessment and Management
- Conduct risk assessments using tools such as FMEA (Failure Modes and Effects Analysis) to identify potential hazards and mitigate risks.
- Collaborate with cross-functional teams to develop and implement risk mitigation strategies.
Continuous Improvement:
- Identify opportunities for process improvement and implement changes to enhance efficiency and product quality.
- Stay current with industry trends, regulatory changes, and best practices in validation engineering.
Profile
The successful Quality Validation Engineer will have the following:
Required:
- Prior experience with validation protocols (IQ, OQ, PQ)
- Root Cause Analysis experience
- Independent time management and communication skills
Highly Desirable:
- Metrology experience- Ideally with Calypso (Zeiss CMM software)
- Minitab experience
- Injection molding exposure
Job Offer
The client can offer the following:
- Competitive Base Salary
- Bonus Potential
- Terrific Benefits
- Growth opportunities for advancement within the organization
APPLY TODAY! All relevant applicants will receive follow up within 72 hours.
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