Abbott · 1 day ago
Associate Product QA Specialist
United States - California - Temecula
Full-time
Onsite
New Grad, Entry Level
$51K/yr - $101K/yr
0+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Associate Product QA Specialist will be responsible for analyzing customer complaints to determine regulatory reportability and ensuring compliance with Good Manufacturing Practices (GMPs). This role involves drafting regulatory reports and communicating investigation results to various stakeholders.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
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
Begins establishing and cultivating a network of internal resources to facilitate completion of tasks
Individual influence is typically exerted at the peer level
Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks
May exercise authority within pre-established limits and approval
Failure to achieve results can normally be overcome without serious effect on the business
Qualification
Required
Bachelor's Degree in Engineering field or an equivalent combination of education and work experience
0-2 years of related experience
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
Learns to use professional concepts and company policies and procedures to solve routine problems
Works on problems of limited scope
Minimal independent decision making
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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