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Quality Manufacturing Engineering Manager

2 months ago

Atlanta, Georgia, United States Abbott Full time
About the Role

We are seeking a highly skilled Quality Manufacturing Engineering Manager to join our team at Abbott. As a key member of our Heart Failure Division, you will be responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support.

Key Responsibilities
  • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel.
  • Leads multifunctional teams in completing program directed or continuous improvement activities.
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Design and conduct experiments for process optimization and/or improvement.
  • Appropriately document experiment plans and results, including protocol writing and reports.
  • Lead process control and monitoring of CTQ parameters and specifications.
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Lead the investigation, resolution and prevention of product and process nonconformances.
  • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
  • Lead in the completion and maintenance of risk analysis.
  • Work with design engineering in the completion of product verification and validation.
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
Requirements
  • BS degree in Engineering or Technical Field or equivalent experience plus 8+ years experience.
  • Demonstrated supervisory experience.
  • Engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Solid communication and interpersonal skills.
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Demonstrates technical leadership within the department and outside the department.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Prior medical device experience.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • ASQ CQE or other certifications preferred.
  • Experience working in a broader enterprise/cross division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel approximately 10%.
About 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.

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 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.

Join our team and be part of a company that is committed to making a difference in people's lives.