Abbott
Product Quality Assurance Analyst II
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines, and we have 114,000 colleagues serving people in more than 160 countries. Working at Abbott
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, named one of the most admired companies in the world by Fortune. A company recognized as one of the best big companies to work for, including diversity, working mothers, female executives, and scientists. The Opportunity
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. 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. Participating in design reviews as required, providing technical inputs and historical information for product controls. Drafting, reviewing, and implementing process improvements through procedures and work instructions. Collating and interpreting team metrics. Compiling, manipulating, and drafting presentable team data for post‑market surveillance reviews. May support the coordination and execution of field actions as they arise, including assisting with progressing associated documentation. Collating quality hold data for product accountability. Providing direction to junior staff on daily activities. Providing recommendations for product control and risk evaluations. Escalating issues to management and serving as a delegate for management in audit settings. Communicating directly to Customer Service, Sales & 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 the PQA archival system. Required Qualifications
Bachelor’s degree with a minimum of 6 years of relevant work experience (risk management, technical writing, and/or post‑market surveillance activities) or equivalent education and work experience. Minimum 3 years at a senior specialist level. Prior experience in the medical device industry and/or quality systems. Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO 14971, and 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. Position Details
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Quality Assurance. Compensation
Base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted. Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines, and we have 114,000 colleagues serving people in more than 160 countries. Working at Abbott
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, named one of the most admired companies in the world by Fortune. A company recognized as one of the best big companies to work for, including diversity, working mothers, female executives, and scientists. The Opportunity
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. 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. Participating in design reviews as required, providing technical inputs and historical information for product controls. Drafting, reviewing, and implementing process improvements through procedures and work instructions. Collating and interpreting team metrics. Compiling, manipulating, and drafting presentable team data for post‑market surveillance reviews. May support the coordination and execution of field actions as they arise, including assisting with progressing associated documentation. Collating quality hold data for product accountability. Providing direction to junior staff on daily activities. Providing recommendations for product control and risk evaluations. Escalating issues to management and serving as a delegate for management in audit settings. Communicating directly to Customer Service, Sales & 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 the PQA archival system. Required Qualifications
Bachelor’s degree with a minimum of 6 years of relevant work experience (risk management, technical writing, and/or post‑market surveillance activities) or equivalent education and work experience. Minimum 3 years at a senior specialist level. Prior experience in the medical device industry and/or quality systems. Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO 14971, and 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. Position Details
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Quality Assurance. Compensation
Base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted. Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
#J-18808-Ljbffr