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Abbott · 1 month ago

Product Quality Assurance Analyst II

United States - California - Alameda

Full-time

Onsite

Senior Level

$98K/yr - $196K/yr

6+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Product Quality Assurance Analyst II will serve as a facilitator to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations and other non-conformities related to products sold by Abbott Diabetes Care.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Reviewing customer complaints, exception reports, technical investigations, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues

Facilitate cross functional meetings to make recommendations on the need for product controls and or risk evaluations

Initiating and facilitating product control processes and documentation

Drafting, reviewing, and issuing stop shipments, quality holds, and dispositions in alignment with the exception report processes as applicable

Initiating and facilitating the risk evaluation processes

Drafting, reviewing, and closing risk evaluations with inputs from cross functional teams

Preparing and participating or facilitating in regular meetings with Senior Level management

Coordinating slides, meeting minutes, and action items

Participate in design reviews as required providing technical inputs and historical information for product controls

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

Collate and interpret team metrics

Compile, manipulate, and draft presentable team data for Post-Market Surveillance reviews

May support the coordination and execution field actions as they arise, including assisting with progressing associated documentation

Collate Quality Hold data for product accountability

Provides direction to junior staff on daily activities

Provides recommendations for product control and risk evaluations

Escalate issues to Management and serve as delegate for management as appropriate in audit settings

Communicate directly to Customer Service, Sales and Marketing, and other affected areas of the business for new issues as well as product releases

Responsible for adhering to quality policies

Maintaining original files in PQA archival system

Qualification

Risk ManagementPost Market SurveillanceFDA RegulationsTechnical WritingProject ManagementCommunication SkillsTeam Collaboration

Required

Bachelors Degree with a minimum of 6 yrs of relevant work experience (Risk Management, Technical Writing and/or Post Market Surveillance activities) or equivalent education and work experience will be accepted

Minimum 3 yrs at a Senior Specialist level required

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