Senior Clinical Quality Associate (on-site)

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, 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.

The Opportunity

Our location in Maple Grove, MN, currently has an opportunity for a Senior Clinical Quality Associate.  This new team member will be 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.

This position could also be based out of our St. Paul, MN; Sylmar, CA; Santa Clara, CA; or Plano, TX sites.

THIS IS AN IN-HOUSE POSITION - NO REMOTE and NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

What You’ll Work On

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

• 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.

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.

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.

Required Qualifications

• Bachelor’s Degree OR an equivalent combination of education or work experience.  
• Minimum 5 years of medical devices, clinical research experience, or related industry.

Specific Skills