AQR Quality Program Manager Technical Design Quality

Abbott Laboratories-posted 3 months ago
$127,300 - $254,700/Yr
Full-time • Mid Level
Green Oaks, IL
Computer and Electronic Product Manufacturing
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Working 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. 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. Abbott is 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. The company is also 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.

  • Provide corporate-wide support of Abbott's Quality System and product submissions.
  • Support US IVD product submission reviews and consultation in matters of Quality System and regulatory compliance.
  • Serve as a corporate liaison and technical expert primarily to the Abbott in vitro diagnostics businesses.
  • Develop and provide a strategic framework through the technical review process for product submissions.
  • Develop a standard interpretation of regulatory guidance and feedback for Abbott and facilitate deployment to the divisions.
  • Assess and communicate key metrics related to product submissions and facilitate implementation of best practices in design and development.
  • Provide senior management with assessment of submission risks and potential impacts to both regulatory submissions and sustainability of commercialized products.
  • Organize, perform detailed review, and comprehend large volumes of complex and technical data.
  • Analyze and develop recommendations for actions necessary to support product submissions based on identified risks.
  • Effectively communicate product submission review feedback to all levels of the organization.
  • Lead and facilitate both AQR internal and external meetings to support the review of the product submissions.
  • Establish, evaluate and communicate submission review process metrics based on Power BI analysis.
  • Develop training, seminars, workshops and/or other appropriate forums to share information and learnings acquired from the technical review process.
  • Provide ongoing coaching to Abbott businesses throughout the design and development process.
  • Monitor new or changing regulatory requirements.
  • Understand and apply industry lab standards and guidance (e.g. CLSI).
  • A Bachelor's degree in technical or science related discipline is required.
  • Minimum 8 years in product design and development and/or technical support desired.
  • Class III or II in vitro diagnostics device background.
  • Demonstrated understanding of domestic regulatory requirements and regulating bodies preferred.
  • Advanced degree is preferred, but not required.
  • Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
  • Excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit for getting a bachelor's degree.
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