Abbott
Product Quality Analyst III
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. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: 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 student debt program, and 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. The Opportunity 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. What You'll Work On 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. Facilitating 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. Assisting 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. Escalating 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. Providing direction to junior staff on daily activities. Escalating issues to Management and may serve as delegate for management as appropriate in various capacities. Collating Risk Evaluation and Product Containment, and associated complaint data, and drafting summary slides for Post-Market Surveillance review activities. Supporting audit activities including compiling lists, pulling and reviewing PQA documents, and working on audit responses. Reviewing 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. Leading issue escalation activities including Risk Evaluation Executive Management Reviews. Identifying the need for, managing, and implementing team process improvement projects/activities. Responsible for adhering to quality policies. Maintaining original files in PQA archival system. Required Qualifications 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 Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $112,000.00
$224,000.00. In specific locations, the pay range may vary from the range posted.
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. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: 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 student debt program, and 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. The Opportunity 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. What You'll Work On 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. Facilitating 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. Assisting 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. Escalating 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. Providing direction to junior staff on daily activities. Escalating issues to Management and may serve as delegate for management as appropriate in various capacities. Collating Risk Evaluation and Product Containment, and associated complaint data, and drafting summary slides for Post-Market Surveillance review activities. Supporting audit activities including compiling lists, pulling and reviewing PQA documents, and working on audit responses. Reviewing 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. Leading issue escalation activities including Risk Evaluation Executive Management Reviews. Identifying the need for, managing, and implementing team process improvement projects/activities. Responsible for adhering to quality policies. Maintaining original files in PQA archival system. Required Qualifications 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 Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $112,000.00
$224,000.00. In specific locations, the pay range may vary from the range posted.