Job Details

Product Quality Assurance Analyst II

Abbott 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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

The primary function of a Product Quality Assurance Analyst II is to 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, manufacturing deviations, trend analysis or other non-conformities related to products sold by Abbott Diabetes Care (ADC).

What you'll work on:

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

Required qualifications:

• 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.