Sr. Clinical Quality Associate

About this role

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: 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  

Internal/External Audits  

· Key player in the preparation and overall support for internal and external audits, including responding to audit findings such as through the CAPA process  

· May perform internal compliance assessments and/or audits  

· Support project teams in preparation for regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit  

May support other clinical quality tasks as requested and as   need arises .  

Position Accountability / Scope:  

 Job/Technical Knowledge:  

· Strong understanding of Good Clinical Practice (GCP) including U.S. regulations and international standards, Quality Assurance/Control, as well as of relevant regulations and procedures  

· Cooperation/Teamwork: team player with autonomy capable of working independently under minimal supervision  

· Planning and organizational   skills:   organizes self in an efficient manner  

· Problem   solving:   gathers information before making decisions; weighs alternatives against   objectives   and arrives at reasonable decisions  

· Adaptability:   remains   open-minded; performs a wide variety of tasks and changes focus quickly as demands change  

· Initiative /   Innovation:   explores alternative successful ways of working and tools; able to challenge conventional practices; creates novel solutions to problems  

EDUCATION AND EXPERIENCE YOU’LL BRING:  

REQUIRED QUALIFICATIONS  

• Bachelors   Degree   (± 16 years), In related field OR an equivalent combination of education and work experience  

• Minimum 4 years, Related work experience with a solid understanding of   specified   functional area.  

• Broad knowledge and application of business concepts,   procedures   and practices.   

• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.   

• Learns   to use professional concepts and company policies and procedures to solve routine problems.   

• Works on problems   of   limited scope.   

• Independent decision making   required .  

PREFERRED QUALIFICATIONS   

Prefer a t least 5 years of medical devices, clinical research experience, or related industry. Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment.   Prefer   GCP audit experience.  

WHAT WE   OFFER :  

At Abbott, you can have   a good job   that can grow into   a great career . We offer:  

A fast-paced work environment where your safety is our priority  

Training and career development, with onboarding programs for new employees and tuition   assistance  

Financial security through competitive compensation,   incentives   and retirement plans  

Health care and well-being programs including medical, dental, vision,   wellness   and occupational health programs  

Paid time off  

401(k) retirement savings with a generous company match  

The stability of a company with a record of strong financial performance and history of being acti

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