Highly Skilled THV Quality Assurance Specialist
22 hours ago
At Entegee, we are seeking a highly skilled THV Quality Engineer to investigate product quality issues, perform device testing, and manage complaint investigations in the medical device industry. This role is perfect for individuals with a passion for quality assurance and a desire to make a meaningful impact.
Key Responsibilities
As a THV Quality Engineer at Entegee, you will be responsible for investigating complex product quality and compliance issues from the field, analyzing results to determine root causes or probable causes. You will also perform hands-on device investigation using various test equipment to determine root cause, assess events against risk documentation for clinical/compliance risks, and escalate as necessary. Additionally, you will participate in escalation tasks such as Project Risk Assessments (PRA) and Corrective/Preventive Actions (CAPAs), SCARs based on investigation findings.
Requirements
To be successful in this role, you will need to have a Bachelor's degree in engineering with 0-2 years of related work experience. You should have experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis, as well as proficiency with the Microsoft Office suite. It would be beneficial to have experience performing functional, physical, and visual testing of medical equipment in a laboratory setting, a basic understanding of statistical techniques, solid knowledge of engineering principles, theories, and concepts, and familiarity with Quality systems and adherence to their regulations.
Preferred Skills
We are looking for candidates with experience in the medical device field, particularly in cardiovascular, endovascular, or critical care/surgical products. A good understanding of documentation skills, strong communication and interpersonal relationship abilities, and previous experience working with lab/industrial equipment would be advantageous.
Benefits
Entegee offers a competitive salary range of $35-$40 per hour, along with comprehensive benefits, including medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our benefit offerings provide employees with the flexibility to choose the type of coverage that meets their individual needs. We also offer paid leave, including Paid Sick Leave where required by law, any other paid leave required by Federal, State, or local law, and Holiday pay upon meeting eligibility criteria.
About Entegee
Specializing in custom automation projects, Entegee is a major player in the world of controls and robotic solutions around the world. We are committed to expanding our team members' resumes and building them to be top-performing controls engineers.
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