Apply on Employer Site

Abbott · 2 months ago

Product Quality Assurance Analyst III

United States - California - Alameda

Full-time

Onsite

Senior Level, Lead/Staff

$112K/yr - $224K/yr

8+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Product Quality Assurance Analyst III role involves identifying and assessing the impact of product nonconformances, managing product containment activities, and facilitating Risk Evaluations. The position is based in Alameda, CA, and requires collaboration with cross-functional teams to ensure product quality and compliance.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Reviewing escalated customer complaints, exception/ nonconformance reports, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues and Risk Evaluations as required

Facilitate cross functional meetings to make recommendations on the need for product control and/or Risk Evaluations

Drafting, reviewing, and issuing stop shipments, quality holds and digital product containment activities, and subsequent product dispositions in alignment with the nonconformance/ exception report processes as applicable

Assist in completing product accountability for Quality Holds

Initiating and facilitating the Risk Evaluation processes, including facilitating cross-functional team recommendations as a result of the Risk Evaluations

Drafting, reviewing, and managing the approval of Risk Evaluations with input from cross functional teams

Preparing and participating or facilitating in Risk Evaluation Executive Management Review meetings with Senior Level management

Escalate grey market, diverted, counterfeit, or stolen product issues to Global Product Protection

Draft, review and implement process improvements through procedures and work instructions

May assist with drafting and execution of field actions as they arise, along with Advisory Notices, and associated documents

Provides direction to junior staff on daily activities

Escalate issues to Management and may serve as delegate for management as appropriate in various capacities

Collate Risk Evaluation and Product Containment, and associated complaint data, and draft summary slides for Post-Market Surveillance review activities

Support audit activities including compiling lists, pulling and reviewing PQA documents, and working on audit responses

Review investigation reports related to new, previously unidentified product defects/ deficiencies, that require a Risk Evaluation

Reviewing emerging global regulations for the impact on PQA processes

May review Risk Evaluations and other PQA documentation from junior team members and provide constructive feedback

Lead issue escalation activities including Risk Evaluation Executive Management Reviews

Identify the need for, manage, and implement team process improvement projects/ activities

Responsible for adhering to quality policies

Maintaining original files in PQA archival system

Qualification

Risk ManagementFDA RegulationsTechnical WritingQuality SystemsProject ManagementCommunication SkillsTeam Leadership

Required

Bachelors Degree with a minimum of 8 yrs of experience or equivalent education and work experience will be accepted

Related work experience, especially in product Risk Management for medical devices, customer complaints, and product nonconformances. Prior experience in the medical device industry and/ or quality systems are required

Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as well as complaint handling systems

Proven track record of managing projects from initiation to completion in a timely manner

Strong technical writing skills and excellent oral and written communication skills