Quality Assurance Specialist II

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 109,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Quality Assurance Specialist II is within our Toxicology Business Unit located in San Diego, CA.

This role will primarily be focused on performing customer complaint investigation and write report; execute verification or validation protocols and reports.

Test and analysis of products.

Generate or revise QC/QA related documents as needed.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES: Aid in implementing process improvements with respect to Quality Assurance processes Maintain Quality metrics as required Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations Provide support to QA activities for regulatory compliance, (i.e.

Management Review support, regulatory audits) Work with managers to coordinate training requirements for employees as required Manage training program and organizational chart as required Perform Quality System Training Requirements as needed Review/approve supplier surveys and make recommendations as required Assist with internal audits and agency audits Manage Document Control as required Manage equipment maintenance and calibration program as required Assist with equipment, process and facility qualification and validation activities as required Release lots to Production Review Raw Material Specification QC Forms Mentor and train junior level associates Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Carries out duties in compliance with established business policies Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies Perform other duties and projects as assigned MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE: BS/BA degree or equivalent in chemistry, biology, or other scientific discipline Minimum of two-five years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 1-3 years of progressively responsible positions.

Minimum of 3 years of experience in managing training program, coordinating training requirements and/or implementing On the Job training.

PREFERRED QUALIFICATIONS: Knowledgeable of federal and other regulations, e.g.

QSR’s, ISO, ISO 13485, CMDR Experience with 21 CFR 820, ISO 13485 Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor Goal oriented, learns quickly, works in a collaborative manner with other departments.

Strong writing and verbal communication skills.

Must be detail-orientated, self-motivated and available for flexible scheduling Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio COMPETENCIES: Analytical skills Drives for results Attention to detail Initiative Communication Adaptability An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.