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Quality Assurance Engineer

2 months ago


Sturgis, Michigan, United States Abbott Laboratories Full time
About the Role

We are seeking a highly skilled Quality Assurance Engineer to join our team at Abbott Laboratories. As a Quality Assurance Engineer, you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Key Responsibilities
  • 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, coach, and mentor non-exempt and entry level exempt personnel
  • Assist 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
  • Participate in or 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
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Requirements
  • Bachelor's Degree plus 2-5 years of relevant experience in Quality Assurance, Manufacturing or Engineering experience OR Master's Degree plus 1-3 years of relevant experience in Quality Assurance, Manufacturing or Engineering
  • Demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP
  • Strong project management and leadership skills
  • 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).
  • 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.
Preferred Qualifications
  • Experience working in a broader enterprise/cross-division business unit model
  • ASQ Certified Quality Engineering Certificate
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.

We offer a comprehensive benefits package, including competitive compensation, incentives and retirement plans, as well as health care and well-being programs, including medical, dental, vision, wellness and occupational health programs. We also offer tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.

At Abbott Laboratories, you can have a good job that can grow into a great career. We offer a stable company with a record of strong financial performance and history of being actively involved in local communities. We are an Equal Opportunity and Military/Veteran friendly Employer, committed to employee diversity.