The Opportunity

This position works out of our Temecula, CA location in the Abbott Vascular Division.Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Our location in Temecula, CA currently has an opportunity for a Associate Product QA Specialist

THIS IS AN ONSITE DAILY POSITION.

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.
• 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.

Bachelors Degree Required

• 0-2 years of related work experience with a basic understanding of specified functional area.
• 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.

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer :

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Last updated : 2024-04-24