Abbott Senior Quality Engineer - Distribution in Roseville, Minnesota

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking a high achieving Senior Quality Engineer to be responsible for developing and maintaining quality engineering methodologies and support within our manufacturing and distribution environments.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are collaborative, dynamic and progressive. We value people with new ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • You will help identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products

  • You will lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

  • Lead, coach, and mentor your non-exempt and entry level exempt team members.

  • Participate 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

  • You will design and conduct experiments for process optimization and/or improvement

  • Appropriately develop and document Quality plans and reports

  • Lead process control and monitoring of CTQ parameters and specifications

  • Lead and implement various process improvement methodologies

  • Lead the investigation, resolution and prevention of 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

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS).

  • Follows U.S. Food and Drug Administration (FDA) regulations, Company policies, operating procedures, processes, and task assignments

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

  • Performs other related duties and responsibilities, on occasion, as assigned

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred

  • 5+ years’ experience

  • Engineering experience and shown use of Quality tools/methodologies

  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

  • Shown communication and interpersonal skills

  • Advanced computer skills, including statistical/data analysis and report writing skills

  • Able to excel in a highly matrixed and geographically diverse business environment

  • Ability to work within a team and as an individual contributor in a dynamic, 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 travel approximately 10%

  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

  • 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

  • Prior medical device experience preferred

  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

  • ASQ CQE or other certifications preferred

  • SAP system experience

  • Distribution experience

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com