Abbott
Manager Product Surveillance
Abbott, Plano, Texas, us, 75086
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 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.
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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world and named one of the most admired companies in the world by Fortune.
A company that’s recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
MAIN PURPOSE OF ROLE
Manage team of data analysts and responsible for creating, revising and implementing metrics, KPIs for the divisional and/or corporate leadership.
MAIN RESPONSIBILITIES
• Responsible for communicating KPI’s and product performance to local and divisional senior management.
• Responsible for ensuring that the group generates and reports metrics (e.g. complaints and product performance) to help to identify potential issues and areas for improvement (e.g. Design or Operations functions).
• To ensure the team monitors product performance in the field and translates the performance information into metrics to support product improvements for the division's manufactured and distributed product.
• To manage and develop a team of employees within the managers area of responsibility and be accountable for their performance whilst providing direction to ensure metrics (e.g. complaint metrics) are generated and necessary work performed in a timely manner (e.g. complaint investigations), maintaining regulatory compliance and optimizing productivity.
• To manage the Analysis Team in accordance with established divisional and Abbott procedures, ensuring compliance to FDA, ISO and worldwide regulations.
• To manage the effective tracking and trending of necessary metrics (e.g. complaints and follow up investigations) in a timely manner in accordance with divisional requirements ensuring compliance to applicable regulations.
• Seek ways to drive through improvements in terms of productivity, quality and cost control in line with Business Excellence initiatives.
• To ensure the Data Analysis team monitors product performance in the field and translates the performance information into metrics to support product improvements for divisional manufactured and distributed product.
• Generate local and world wide monthly trend reports, produce trend related queries and ensure trend procedures are in accordance to divisional and corporate requirements and meet appropriate regulatory guidelines and regulations (e.g. FDA, ISO 13485, & Medical Device/IVD).
• Oversee the investigation into all trends highlighted as part of the monthly process, and highlight any significant unresolved issues to senior management as required.
• Prepare and present complaint information for Management Review.
QUALIFICATIONS
Education Level: Bachelor's Degree
Major/Field of Study: Math, Science, or Engineering disciplines preferred) or equivalent in a technical or analytical discipline OR an equivalent combination of education and work experience
Experience:
Minimum 5 years - Overall quality experience in a FDA/ISO regulated environment
Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)
Experience of product performance monitoring activities in a relevant industry/discipline
Preferred Qualifications
Experience working in a broader enterprise/cross-division business unit model preferred.
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
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 .
The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world and named one of the most admired companies in the world by Fortune.
A company that’s recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
MAIN PURPOSE OF ROLE
Manage team of data analysts and responsible for creating, revising and implementing metrics, KPIs for the divisional and/or corporate leadership.
MAIN RESPONSIBILITIES
• Responsible for communicating KPI’s and product performance to local and divisional senior management.
• Responsible for ensuring that the group generates and reports metrics (e.g. complaints and product performance) to help to identify potential issues and areas for improvement (e.g. Design or Operations functions).
• To ensure the team monitors product performance in the field and translates the performance information into metrics to support product improvements for the division's manufactured and distributed product.
• To manage and develop a team of employees within the managers area of responsibility and be accountable for their performance whilst providing direction to ensure metrics (e.g. complaint metrics) are generated and necessary work performed in a timely manner (e.g. complaint investigations), maintaining regulatory compliance and optimizing productivity.
• To manage the Analysis Team in accordance with established divisional and Abbott procedures, ensuring compliance to FDA, ISO and worldwide regulations.
• To manage the effective tracking and trending of necessary metrics (e.g. complaints and follow up investigations) in a timely manner in accordance with divisional requirements ensuring compliance to applicable regulations.
• Seek ways to drive through improvements in terms of productivity, quality and cost control in line with Business Excellence initiatives.
• To ensure the Data Analysis team monitors product performance in the field and translates the performance information into metrics to support product improvements for divisional manufactured and distributed product.
• Generate local and world wide monthly trend reports, produce trend related queries and ensure trend procedures are in accordance to divisional and corporate requirements and meet appropriate regulatory guidelines and regulations (e.g. FDA, ISO 13485, & Medical Device/IVD).
• Oversee the investigation into all trends highlighted as part of the monthly process, and highlight any significant unresolved issues to senior management as required.
• Prepare and present complaint information for Management Review.
QUALIFICATIONS
Education Level: Bachelor's Degree
Major/Field of Study: Math, Science, or Engineering disciplines preferred) or equivalent in a technical or analytical discipline OR an equivalent combination of education and work experience
Experience:
Minimum 5 years - Overall quality experience in a FDA/ISO regulated environment
Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)
Experience of product performance monitoring activities in a relevant industry/discipline
Preferred Qualifications
Experience working in a broader enterprise/cross-division business unit model preferred.
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
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 .
The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com