Quality Assurance Specialist
2 hours ago
Entegee is seeking a highly skilled Quality Engineer II to join our team. As a Quality Engineer II, you will play a critical role in improving value assignment processes, reviewing and revising validation plans, completing risk assessments, and supporting implementation activities.
Key Responsibilities:- Improve value assignment processes and ensure alignment with industry standards
- Review and revise validation plans, including risk assessments in accordance with ISO 14971
- Support implementation activities for new processes and equipment
- Assist with critical QMS investigations related to nonconformances and CAPAs
- Validate new processes and equipment through IQ, OQ, PQ stages
- Collaborate with cross-functional teams to ensure quality and compliance standards are met
- BS Degree in a relevant field
- Experience with risk assessments (ISO)
- Knowledge of IQ, OQ, PQ validation processes
- Experience in Quality Management Systems (QMS) investigations related to nonconformances and CAPAs
- Experience in process improvements and validation plan reviews in the medical device or pharmaceutical industry
- Familiarity with regulatory standards and compliance
Entegee offers a competitive salary range of $38-$48 per hour, as well as a comprehensive benefits package, including medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan.
Our benefits program provides employees with the flexibility to choose the type of coverage that meets their individual needs. We also offer paid leave, including Paid Sick Leave, as required by law, and Holiday pay upon meeting eligibility criteria.
Entegee is an Equal Opportunity Employer/Veterans/Disabled. We consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
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