Abbott
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Quality Assurance Manager
role at
Abbott
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.
Benefits
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 and named one of the most admired companies by Fortune.
A company recognized as one of the best big companies to work for with strong diversity, working mothers, female executives and scientists.
Opportunity As a Quality Assurance Manager for Complaint Investigations, you will sustain the complaint investigation operation, develop a team and lead projects to advance the lab for future expectations with regards to compliance, capabilities and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations and complaint returns, establishes an operation that performs consistently, and develops processes for new or updated products while ensuring ongoing compliance and audit readiness per Abbott’s Quality Policies and Global Regulations.
What You’ll Work On
Oversee complaint investigation lab output and proficiency by developing strong teams and metrics.
Develop and maintain engineering team to advance investigation techniques for execution by direct labor workforce.
Support CAPA initiatives and ongoing projects to ensure ongoing proficiency in complaint investigations operation.
Represent Complaint Investigations lab for audits, projects, and act as subject matter expert for investigations processes.
Develop metrics and presentations for Quality System Management reviews and associated requirements to ensure compliance and maintain performance.
Review and provide functional approval for project and quality system documentation.
Develop and implement plans, ensure milestones are met and prioritize resource workload to meet commitments.
Measure and report performance of personnel and process relative to targets.
Required Qualifications
Bachelor’s degree or an equivalent combination of education and work experience.
Minimum 7 years of experience in a FDA/ISO regulated environment.
Minimum 5 years of experience in Quality.
Preferred Qualifications
Substantial demonstrated initiative and problem‑solving skills; critical‑thinking skills.
Experience in leading & managing a large team of people.
Experience working in process and test method development in a Quality management system, collaborating with Quality Assurance, Operations and R&D.
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
Quality Assurance Manager
role at
Abbott
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.
Benefits
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 and named one of the most admired companies by Fortune.
A company recognized as one of the best big companies to work for with strong diversity, working mothers, female executives and scientists.
Opportunity As a Quality Assurance Manager for Complaint Investigations, you will sustain the complaint investigation operation, develop a team and lead projects to advance the lab for future expectations with regards to compliance, capabilities and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations and complaint returns, establishes an operation that performs consistently, and develops processes for new or updated products while ensuring ongoing compliance and audit readiness per Abbott’s Quality Policies and Global Regulations.
What You’ll Work On
Oversee complaint investigation lab output and proficiency by developing strong teams and metrics.
Develop and maintain engineering team to advance investigation techniques for execution by direct labor workforce.
Support CAPA initiatives and ongoing projects to ensure ongoing proficiency in complaint investigations operation.
Represent Complaint Investigations lab for audits, projects, and act as subject matter expert for investigations processes.
Develop metrics and presentations for Quality System Management reviews and associated requirements to ensure compliance and maintain performance.
Review and provide functional approval for project and quality system documentation.
Develop and implement plans, ensure milestones are met and prioritize resource workload to meet commitments.
Measure and report performance of personnel and process relative to targets.
Required Qualifications
Bachelor’s degree or an equivalent combination of education and work experience.
Minimum 7 years of experience in a FDA/ISO regulated environment.
Minimum 5 years of experience in Quality.
Preferred Qualifications
Substantial demonstrated initiative and problem‑solving skills; critical‑thinking skills.
Experience in leading & managing a large team of people.
Experience working in process and test method development in a Quality management system, collaborating with Quality Assurance, Operations and R&D.
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