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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.

Quality System & Regulatory Compliance Manager

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Your 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.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 a high employer contributionTuition 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Westfield, IN., location in the Structural Heart Medical Device Division.

Structural Heart Business Mission: Why We Exist

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.

The primary function of this position is to provide guidance, direction and strategic leadership in quality and regulatory compliance matters. The Quality System & Regulatory Compliance Manager is responsible for establishing and implementing an internal audit program to effectively assess and report on the site's status relative to defined quality system requirements. Primary responsibilities include planning activities needed to assess the status of the quality system, organizing resources appropriate to execute the identified plan, approving documentation as dictated by procedures and reporting status of key quality and compliance indicators to local and Divisional Management. Supports the quality system by taking action to align the site to Divisional and Corporate objectives. The incumbent facilitates inspections with regulatory agencies.

What You’ll Work On

Assure compliance with the current Good Manufacturing Practices and all applicable standards and regulations.Monitor compliance with Divisional procedures and Corporate policies. Manage all phases of external audits.Serve as Quality Systems Subject Matter Expert and Generalist/Escort.Establish program to promote a culture of Quality and Compliance.Maintain an Inspection Readiness Program with defined compliance enhancement activities.Maintain an effective Internal Audit Program aligned with Divisional schedule/improvement initiatives.Responsible for Document Control and Training areas.Assure Divisional procedures and Corporate policies related to document control and training are properly implemented and maintained.Gather and evaluate quality data for monthly CAB and quarterly Management Review Meetings. Support site's continuous improvement initiatives.Identify and implement Cost Improvement Projects.Foster continuous improvement culture (i.e. lean, six sigma).Additional responsibilities may include: QA Release area, Microbiology Laboratory, Environmental Monitoring Program, Supplier Quality Engineering, among others (as assigned).

Required Qualifications

Bachelor Degree: Chemistry, Biology, Engineering or any other related science; Masters' Degree preferred

Good communications and negotiation skills which would allow assuring the resolution of compliance issues.

High degree of initiative, decision making and responsibility which will enable the incumbent to perform efficiently with a minimum supervision.

Strong regulatory compliance and technical background, statistical knowledge and analytical skills are needed.

A solid knowledge of technical report writing and computer literate is required.

A minimum of 7+years experienced in a Quality or Technical field in the Medical Device/Pharmaceutical related business.

Apply Now

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

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.

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The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.