Quality Assurance Specialist III

Abbott • Westfield, MA

11d • Onsite

About The Position

The Quality Assurance Specialist III 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. This position works out of our Westfield, IN location in the Structural Heart division. 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.

Requirements

• High School Diploma / GED or an equivalent combination of education and work experience
• Minimum 4 years related work experience
• 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.

Nice To Haves

• Associates Degree (± 13 years) or some college credits performed

Responsibilities

• 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.

Benefits

• 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED