Quality System Analyst Intermediate

JOB DESCRIPTION:

Quality System Analyst Intermediate

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.

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. Youll 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 bachelors 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.

The Opportunity

We are currently seeking a highly capable Quality System Analyst Intermediate to support Abbotts Structural Heart (SH) Division at our Westfield IN location. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

In this role you will establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws regulations guidances and standards (LRGS).

What Youll Work On

• Identify internal requirements and external laws regulations guidances and standards (LRGS) applicable to one or more of Abbotts quality systems.
• Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in Abbott business processes.
• Identify areas of potential noncompliance within Abbott.
• Review and update the Quality System Manual as needed.
• Educate functional areas on quality system requirements.
• Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
• Mediate resolution of interdepartmental and cross business unit process conflicts.
• Identify qualified external consultants and experts in government collaborating with them to insure correct interpretation of LRGS.
• Collect business process data from different parts of the company for analysis.
• Act as an expert resource in specific LRGS requirement knowledge for Abbott.
• May be responsible for identifying training requirements programs and tracking systems.
• Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
• May demonstrate basic project management skills by acting as a project lead on small well defined projects.
• Provides guidance to less experienced staff.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans organizes and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
• Owns and facilitates site Quality System by collaborating with nonconformance/CAPA owners to ensure robust compliant CAPAs and compliance with Abbotts timeliness requirements.
• Provide resource and strategy support during internal and external compliance audits and inspections including leading audit resource team managing logistics leading backroom support or other audit need.

Required Qualifications

Education

• Bachelors Degree ( 16 years) in Engineering or Technical Field or an equivalent combination of education and work experience

Experience/Background

• 2-5 years of related work experience with a good understanding of specified functional area.

• Working 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.

• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

• Exercises judgement within defined procedures and practices to determine appropriate action.

• Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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