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Sr. Quality Engineer Risk Management (San Diego)

Sr. Quality Engineer Risk Management (San Diego)

AbbottSan Diego, CA, US
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Sr. Quality Engineer Risk Management

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.
  • 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

As a Sr. Quality Engineer Risk Management, you will serve as a Subject Matter Expert (SME) responsible for developing and maintaining quality systems, subsystems, and key processes related to Risk Management. You will also provide quality engineering support across new product development, manufacturing, and / or system and service support.

What You'll Work On

  • Implement and maintain the effectiveness of the Risk Management Quality System element
  • Interpret regulations and requirements to lead, coach, and mentor teams on Risk Management
  • Serve as SME for domestic and international sites and affiliates regarding Risk Management
  • Estimate project effort and resource requirements by collaborating with appropriate staff
  • Participate in or lead teams supporting quality disciplines and risk management practices
  • Direct project execution : assign tasks, track schedules, identify risks, and develop contingency plans
  • Resolve project issues by collaborating with team members and stakeholders
  • Interface with management and cross-functional teams on significant matters
  • Lead and implement improvement methodologies related to Risk Management
  • Mentor and train new product development and sustaining engineering teams on product risk assessments
  • Guide engineering staff in preparing Health Risk Assessments
  • Required Qualifications

  • Bachelors' degree in engineering or Technical Field.
  • 5+ years' experience working in a broader enterprise / cross-division business environment.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and / or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to maintain regular and predictable attendance.
  • Advanced computer skills, including statistical / data analysis and report writing skills.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Experience with risk management (ISO 14971) required.
  • Preferred

  • Experience working in a broader enterprise / cross-division business unit model preferred
  • Prior medical device experience preferred.
  • Knowledge of devices used for PTCA and PTA preferred.
  • Knowledge of various tools and techniques for Risk Management preferred.
  • Knowledge of IEC60601-1 or electrical safety preferred.
  • 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.

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    Sr Quality Engineer • San Diego, CA, US

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