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    Senior Quality Engineer - Minnetonka, United States - Abbott

    Abbott
    Abbott Minnetonka, United States

    5 days ago

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    Description

    The Opportunity

    This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division.

    As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

    Senior Quality Engineer this position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

    What You'll Work On
  • 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 nonconformance's
  • 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
  • Performs other related duties and responsibilities, on occasion, as assigned.
    • EDUCATION AND EXPERIENCE YOU'LL BRING
  • Bachelors Degree Engineering or Technical Field OR an equivalent combination of education and work experience
  • Minimum 5 years
  • Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO Solid communication and interpersonal skills. Strong project management and leadership skills, including the demonstrated ability to lead multidepartmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Experience working in a broader enterprise/cross-division business unit model preferred. 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.
    • *
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