Product Quality Assurance Analyst III

About the position

The primary function of a Product Quality Assurance Analyst III is to assist in identifying, reviewing and facilitating assessments of the impact of worldwide product nonconformances on ADC products that arise as the result of complaint investigations, manufacturing deviations, trend analysis or software defect reviews. This may include managing the completion of product containment activities and Risk Evaluations, and associated activities addressing the product nonconformances, and including the escalation of higher risk nonconformances to executive management. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

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.

Requirements

• 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.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.