Sr Quality Engineer at Entegee

Job Summary: Seeking a Senior Quality Engineer with expertise in Process Validation, Computer Software Validation, and Equipment Qualification to ensure the highest standards in the manufacturing of medical devices.

Job Requirements:

• Expertise in Validation skills including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation), CSV (Computer Software Validation), and Equipment Validation.
• Experience in Manufacturing Process Improvements.
• Proficiency in updating Process Failure Mode and Effects Analysis (pFMEA).
• Experience working with Disposable Medical Devices or capital equipment is highly desirable.

Job Responsibilities:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing teams to ensure quality standards are integrated and maintained throughout production processes.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess costs and determine responsibility for non-conformance.
• Ensure that corrective measures meet acceptable reliability standards and that all documentation is compliant with regulatory requirements.

Additional Information:

• Position is 100% onsite.
• Focus on continuous improvement and adherence to quality assurance standards in a highly regulated environment.
• Required to engage in ongoing professional development to keep up-to-date with industry standards and technological advancements in quality engineering.

Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.