Abbott Associate Product Quality Analyst in Temecula, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
Apply codes to events to facilitate product performance records.
Review coding and investigations with engineering, laboratory, and other internal staff.
Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
(Influence/Leadership) Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
Individual influence is typically exerted at the peer level.
(Planning/Organization) Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
(Decision Making/Impact) May exercise authority within pre-established limits and approval.
Failure to achieve results can normally be overcome without serious effect on the business.
Bachelor's degree plus 0-2 years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience.
(Technical/Business Knowledge (Job Skills)) General knowledge and basic application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
(Cognitive Skills) Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. Minimal independent decision making.
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 firstname.lastname@example.org