Senior Specialist Quality Assurance

Abbott • Lake Forest, CA

1d • $78,000 - $156,000 • Hybrid

About The Position

The Senior Specialist, Quality Assurance role is part of our Molecular Diagnostics Business Unit and is based at either our Des Plaines, IL or Lake Forest, IL location. This role will conduct quality-related activities in the area of Complaint Handling to deliver consistent, high-quality documents, services, products, and processes that add value to the business. The primary function of the Quality Specialist is to assist in maintaining the quality system.

Requirements

• Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
• Direct experience in a Quality or Regulatory Affairs role in a GMP related industry
• Demonstrates understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.
• Candidate should be flexible, have strong problem-solving skills, excellent written and oral communication skills, and be able to lead cross functional teams.

Nice To Haves

• Experience with post-market quality
• Experience participating in or supporting both internal and external audits
• Working knowledge of ISO 13485 (QMS), 21 CFR, IVDR 2017/746, MDR 2017/745, and other international regulations
• Experience with medical devices containing software
• Experience working with software management systems, such as ERP systems
• Proficient in Microsoft Office Word, Excel, and PowerPoint
• Must have the ability to support business needs across different time zones, as needed
• Excellent written and oral communication skills
• Strong organizational and prioritization skills

Responsibilities

• Complaints Coordination, Postproduction Risk, CAPA, Surveillance and Maintenance, Field Actions, Metrics, etc.
• Assist with other support duties as assigned.
• Participate in the Corrective Action/Preventive Action (CAPA) process, including the investigation of failures or deviations as required.
• Maintain product complaint logs to identify and report recurring issues to Quality Assurance Management and Product Development.
• Collaborate with other internal groups to respond to product inquiries and issues.
• Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
• Collaborate with members of the Quality Assurance team working on special projects.
• Participate on permanent and temporary teams that are process- or project-driven.
• Become familiar with and serve as a subject matter expert on electronic support systems, including TraqWise, CMSNext, SmartSolve, SAP, and related platforms.
• Collect, analyze, and publish quality metrics.
• Assist in the preparation of distribution reports as needed for product information letters and field actions.
• Support the drafting of field action letters and other field action-related documentation.
• Reconcile and maintain field action files, ensuring all documentation is complete and appropriately filed in accordance with corporate/division standards to facilitate easy retrieval for audit support.
• Prepare 806 monthly status reports in support of 21 CFR Part 806 field action requirements.
• Track recall activities through closure and prepare final closure documentation for each field action file.
• Support audit readiness activities for internal (site, division, and corporate) and external (FDA, ISO, BSI, TUV, etc.) audits.
• Handle data requests from other departments pertaining to risk or field action data.
• Serve as a team member and/or leader on projects focused on continuous process improvement.
• May own CAPA activities for department CAPAs.
• Facilitate the post-production risk process in cases involving distributed nonconforming product and may support drafting post-production risk records.

Benefits

• 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 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior