Sr. Clinical Quality Associate

About Abbott 

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents 

Our location in Maple Grove, MN, currently has an opportunity for a Senior Clinical Quality Associate.  This position could also be based out of our Plano, TX site. 

THIS IS AN IN-HOUSE POSITION - NO REMOTE 

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION. 

WHAT YOU'LL DO: 

Primary Job Function: 

Responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements. 

Core Job Responsibilities: 

Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures. 

Study Support 

· Review study documents for compliance to applicable regulations, standards, and internal procedures 

· Act as a resource to clinical study teams regarding compliance to regulations, standards, and Abbott procedures 

· Support compliant execution of clinical research projects 

· Preferably has prior experience with GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155 

CAPA 

· Generate CAPA documentation, including investigations, resolution plans, and implementation reports 

· Ensure work complies with regulatory and compliance standards 

· Work cross-functionally to develop pragmatic and compliant solutions for CAPA activities 

· Drives continuous process improvement 

· Strong written communication skills