Summary: Senior Quality Systems Specialist with a focus on CAPA & Root cause analysis, technical writing, QMS documentation for ISO 13485 & EU MDR compliance.

Requirements:

Degree and minimum of 5 years of experience

Experience with CAPA Management & Root Cause Analysis Tools

Technical writing skills specifically in the creation and review of QMS related documentation for ISO 13485 and EU MDR compliance

Preferred Skills:

Product Service Quality experience

Responsibilities:

Providing technical guidance and quality compliance for various Respiratory related products including ventilators, breathing systems, airways devices, and airway management devices.

Working in partnership with the R&D and OU Quality Teams to maintain compliant quality systems and develop improved strategies for quality.

Ensuring Medtronic's ability to provide customers with high-quality reliable products while staying in compliance with applicable industry standards, regulatory requirements, and customer requirements.

 

 

 

 

Pay Details: $36.00 to $48.00 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.