Sr. Clinical Quality Associate

About Abbott

For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whetheritsglucose 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 than10000 peoplehave healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than500000 peoplewith diabetes from routinefingersticks.

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 YOULL 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 Partsand 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 YOULL 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 conceptsproceduresand 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 compensationincentivesand retirement plans

Health care and well-being programs including medical dental visionwellnessand 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:

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.

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