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Quality Assurance Specialist - Temecula, United States - Bioethic
Description
Our client 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, nutritional's, and branded generic medicines.
Our 103,000 colleagues serve people in more than 160 countries.This position works out of our Temecula, California location in our AVD Vascular business unit. Our solutions are used in hospitals, laboratories, and clinics around the globe.
The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our products are also utilized by laboratory management to ensure efficiency in their operations.Our client provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
THE OPPORTUNITY
TheQuality Assurance Specialist will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business.
WHAT YOU'LL WORK ON
Responsible for issuing customer communications (e.g. Product Recalls/Product Corrections, Product Information Letters) and reconciliation of field actions.
Responsible for issuing Worldwide Quality Holds to global affiliate warehouses and distribution centers.
Responsible for implementing and maintaining the effectiveness of the quality system.
Summarizes/communicates quality metrics that will be used as objective evidence for area performance or monitoring quality system health.
Communicates with internal and external customers to distribute, reconcile, and verify quality records. Maintains auditable quality records and files. Supports internal and/or external inspections such as FDA, ISO, and AQR.
Actively participate in process improvement initiatives to improve Field Quality and/or division processes.
Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees, managers and cross-functional peers.
May lead a project with a limited scope, but usually a contributor on broader projects. Coordinates quality decisions between different quality and other functional areas.
Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions.
Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
Prepare, maintain, and monitor quality system records (e.g., field actions, quality holds, audit requests, etc.) establishing consistency in application.
Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
Provides guidance to other Professionals and Technicians.
Quality System Compliance -Maintains awareness of standards that regulate our industry.
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.Documentation & Change Control - Identifies areas for process improvement. Provides supporting information for change including reasons and justifications.
QUALIFICATIONS
Highschool diploma or GED
Experience in maintaining quality records/documents.
Proficient with Microsoft Suite programs is preferred.
This job description will be reviewed periodically and is subject to change by management.
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