Staff Continuous Improvement Quality Engineer

3 days ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
About the Role

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.

Job Summary

We are seeking a highly skilled Staff Continuous Improvement Quality Engineer to join our Electrophysiology Division. As a key member of our team, you will be responsible for leading process improvements and ensuring the highest quality products are delivered to our customers.

Key Responsibilities
  • Provide leadership to engineering staff regarding process validations and continuous improvement activities.
  • Mentor engineers in the proper methods of process validation, including installation qualification (IQ), operational qualification (OQ), and process qualification (PQ).
  • Use industry standard methodologies (lean, six sigma, DFX, etc.) to drive efficiency improvement across the manufacturing network.
  • Monitor, assess, and improve in-process production, inspection, and assembly performance to ensure customer requirements are maintained and process/business performance metrics meet goals.
  • Determine and drive operations-focused improvement efforts based on data analysis.
  • Oversee the implementation of countermeasures and corrective/preventive actions in support of operations process improvements.
  • Support continuing production, process development, and new product introductions.
  • Participate in cross-functional teams.
  • Review and approve protocol and written reports.
  • Drive continuous improvement of engineering technical capabilities.
  • Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
  • Coach, manage, and develop technical staff.
  • Develop, implement, train, and monitor the effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP, and all other applicable agency regulations.
  • 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
  • Minimum of 8 years of experience in manufacturing/process development leading and supporting continuous improvement programs within medical device manufacturing.
  • Experience conducting and leading process validation activities in medical device manufacturing.
  • Experience with statistical techniques (e.g., DOE, SPC).
  • Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
  • Solid communication skills.
  • Solid knowledge of GMP, ISO regulations.
  • Demonstrated success in leading mfg technology transfer projects to global operations.
  • 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 the ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel approximately, including internationally.
Preferred Qualifications
  • Medical device experience with bioprosthetic heart valve tissue development or manufacturing or other implantable device development strongly preferred.
  • Previous Development Quality Engineering experience.
  • ASQ CQE or other certifications.

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