Staff Auditor, Quality Systems- Medical Devices

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 devicesnutritionalsand branded generic medicines. Our 114000 colleagues serve people in more than 160 countries.

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 have access to:

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution

Tuition reimbursement theFreedom 2 Savestudent debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree.

A company recognized asa great placeto 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 Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whetheritsglucose 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 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.

The Opportunity

Our location in Sylmar CAPleasanton CA orMinnetonka MN currently has an on-site opportunity for aStaff AuditorQuality Systemsprofessional. This new team member will be a leader and mentor responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support.

WhatYoullWork On

Internal audit planning developingaudit schedulesand plansperformingand documenting audits and managing related following up activities including related KPI and metrics reporting.

Support the development training and supervision of auditors to improve their ability to provide inspectionreadinesssupport.

Lead and mentor staff influence colleagues and peers and continually strive to improve the audit andinspection readinessprograms.

BachelorsDegree ( 16 years) Related field OR an equivalent combination of education and work experience

MastersDegree ( 18 years) Preferred

Minimum 6 years Related work experience with a strong understanding of specified functional area.

Solid understanding 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.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable withingenerally definedpractices and policies in selecting methods and techniques for obtaining solutions.

Has a sound knowledge of a variety of alternatives and their impact on their business unit.

Prior experience in the medical device industry and/orquality systems.

Strong working knowledge of regulations and standards applicable to medical devices including FDA Code of Federal Regulations cGMP ISO14971 EUMDR among others.

Proven track record of managing projects from initiation to completion in a timely manner.

Strongtechnical writingskills and excellent oral andwritten communicationskills.

Demonstrated leadership/management skills with respect to achievement of company goals and objectives.

Strongleadershipskillsincludingthe ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Experience working in a broader enterprise/cross-division business unit model. Ability to work in a highly matrixed and geographically diverse business environment.

Prior audit and management experience preferably in Medical Devices.

Prior experience in the preparation and management of external inspections preferably with FDA.

Anticipate 25-50% travel and may have to travel with short notice to perform or support audits.