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Abbott Quality Specialist IV in Westfield, Indiana

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 107,000 colleagues serve people in more than 160 countries

This position will be based in Westfield, IN. However, there will be an initial training period of up to 7 months in Menlo Park, CA. Applicant must be able to spend up to 7 months in Menlo Park before transferring to Westfield location.

Abbott Structural Heart Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

The Quality Assurance Specialist position exists to ensure that all units, either commercial or clinical product, have been manufactured and sterilized in accordance with internal procedures prior to release

Job Duties:

  • Reviews Manufacturing documentation by obtaining all lot history records and non-conforming material reports and ensuring that they are compiled in accordance with internal procedures.

  • Tracks Documentation discrepancies by maintaining a mechanism by which discrepancies with manufacturing documentation can be tracked to determine trends, etc.

  • Notifies Manufacturing personnel of documentation issues by providing feedback immediately upon discovery of issues, and, on a periodic basis, informing manufacturing personnel in a more formal manner of discrepancies with manufacturing documentation.

  • Confines discrepant materials by maintaining a Quarantine area whereby discrepant materials are physically located until they are resolved and can be released.

  • Releases product by performing the necessary transactions in SAP in the sterile cycle to release product upon receipt of the Product Release Authorization and completion of LHR review.

  • Reviews and approves Design History Files by obtaining and verifying the contents of DHFs and approving the Engineering Order authorizing release into the Archive department.

  • Advises Manufacturing personnel and project leaders by functioning as the "expert" in the area of documentation compliance.

  • Coordinates Clinical product by completing appropriate paperwork to release clinical product to approved sites.

  • Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components sub assemblies and documentation.

  • Plans and organizes non-routine tasks w/approval.Initiates or maintains work schedule. Establishes priorities of work assignments.

  • Solves a wide range of complex problems requiring advanced interpretation of generally defined procedures and practices. Selects methods and practices to obtain imaginative, thorough, and practical solutions to questions.

  • Understands organizational structure and positions of key employees Maintains general knowledge of products/services associated with area and employees involved with specific product lines and services.

EXPERIENCE YOU'LL BRING

Required Qualifications

  • H.S. diploma or equivalent plus 5+ years of related work experience or equivalent combination. Two-year degree or some college credits preferred.

Training / Experience Required

  • Applies solid knowledge of business concepts, procedures and practices, and a complete understanding fundamentals in a functional area, and working knowledge of other related disciplines. Will perform this job in a quality system environment.

  • Performs complex assignments usually without established procedures. Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • A fast-paced work environment where your safety is our priority

  • Production areas that are clean, well-lit and temperature-controlled

  • Training and career development , with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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