Senior Quality Assurance Engineer
2 weeks ago
We are seeking a highly skilled Quality Assurance Engineer to support our quality standards and test validation processes in a medical or clinical environment. The ideal candidate will have a strong background in engineering, with a focus on quality assurance and validation.
Key Responsibilities:
- Prioritize, review, and provide direction on test plans and reports
- Ensure testing methods, sample sizes, and acceptance criteria align with design intent
- Develop, modify, and apply quality standards for materials and products
- Collaborate with engineering and manufacturing teams to maintain quality standards
- Design and specify inspection and testing mechanisms
- Conduct quality assurance tests and perform statistical analysis
- Ensure corrective measures meet reliability standards and maintain compliant documentation
- Support process and equipment validation efforts through established protocols
Requirements:
- BS in Engineering (Electrical Engineering preferred)
- Minimum 2 years of relevant experience
- Six Sigma certification or experience
- Experience in medical or clinical environments
- Knowledge of validation processes (IQ/OQ/PQ)
- Familiarity with corrective and preventive actions (CAPA/NCR)
Preferred Skills:
- Statistical analysis expertise
- Knowledge of test methods and equipment validation
- Experience with process and equipment validation protocols (IQ/OQ/PQ/TMV/PD/DOE)
Benefits:
- Competitive hourly rate: $35.00 to $40.00 per hour
- Comprehensive benefits package, including medical, dental, vision, life insurance, short-term disability, and 401K plan
- Opportunities for professional growth and development
Equal Opportunity Employer:
- Entegee is an equal opportunity employer and welcomes applications from diverse candidates
- We are committed to creating an inclusive and respectful work environment
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