Sr. Clinical Quality Associate

About Abbott

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit’sglucose 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 than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinengersticks.

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

Our location inMaple Grove, MN, currently has an opportunity for aSenior Clinical Quality Associate.This position could also bebased out ofourPlano, TXsite.

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 compliancetoapplicable regulations, standards, and internal procedures

· Act as a resource to clinical study teamsregardingcompliancetoregulations, 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 workcomplies withregulatory 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 asneed 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 organizationalskills:organizes self in an efficient manner

· Problemsolving:gathers information before making decisions; weighs alternatives againstobjectivesand arrives at reasonable decisions

· Adaptability:remainsopen-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

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

• Minimum 4 years, Related work experience with a solid understanding ofspecifiedfunctional area.

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

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

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

• Works on problemsoflimited scope. 

• Independent decision making.

PREFERRED QUALIFICATIONS 

Prefer at 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.PreferGCP audit experience.

WHAT WEOFFER :

At Abbott, you can havea good jobthat can grow intoa 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 tuitionassistance

Financial security through competitive compensation,incentivesand retirement plans

Health care and well-being programs including medical, dental, vision,wellnessand 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 actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that providesthe growthand strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us atwww.abbott.com, on Facebook atwww.facebook.com/Abbottand on Twitter @AbbottNews and @AbbottGlobal.