Job 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.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.
MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
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
What's on 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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