**Quality Assurance Manager**, **Quality Control Manager**, **Quality Systems Manager**, **Quality Assurance Lead**, **Quality Control Lead**, **Quality Systems Lead**

5 days ago

Plano, Texas, United States Abbott Laboratories Full time

About Abbott Laboratories

Abbott Laboratories 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 Laboratories

At Abbott Laboratories, 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business is an area of expertise for Abbott Laboratories. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include the ProclaimTM and EternaTM SCS systems, the ProclaimTM DRG Neurostimulator, the only FDA approved DRG therapy and market leading radiofrequency ablation products.

What You'll Work On

  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures and leading audits and inspections.
  • Owns CAPA process and CAPA monitoring.
  • Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Translates department goals into individual objectives and KRAs.
  • Identifies, develops and implements processes to improve department performance.
  • Monitors departmental activities and records to ensure compliance independent action through critical decision making.
  • Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
  • Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Influence/Leadership

  • Promotes the attainment of group goals by selecting, motivating, and training capable staff;
  • Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.

Decision Making/Impact

  • Assignments are expressed in the form of tasks and objectives;
  • Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management;
  • Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Other responsibilities as needed.

Requirements

  • A Bachelor's degree or an equivalent combination of education and work experience.
  • 5+ years of relevant work experience in quality.
  • Ability to monitor progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals.
  • Ability to monitor costs of projects and of human and material resources within a department or unit; ability to monitor external environment in area of technical or professional responsibility.
  • Willingness to perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Ability to develop and/or identify new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program.
  • Ability to investigate and solves problem that impact work processes and personnel within the assigned unit.

Preferred Qualifications

  • Solid knowledge of FDA regulations and guidelines and a deep understanding of medical device industry.
  • Previous work experience with audits.

Base Pay

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.

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