Quality Assurance Engineer II

1 week ago

Minneapolis, Minnesota, United States Abbott 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.

We're seeking a Quality Assurance Engineer II to join our Electrophysiology division in Plymouth, MN. As a key member of our team, you'll be responsible for ensuring our products, processes, and quality records conform to quality standards and establish compliance with the quality system.

Key Responsibilities:

  • Support the CAPA Portfolio for the Electrophysiology (EP) business through effective project and process mentorship with CAPA owners and approvers.
  • Prioritize and communicate timelines of individual CAPA projects to facilitate timely completion per the EP Quality System.
  • Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Proficiently lead meetings and communications for QA system information, concerns, and updates.
  • Ensure database and record storage maintenance and integrity for QA systems.
  • Support execution of CAPA training.
  • Identify and execute continual improvement opportunities within the Abbott CAPA process.
  • Drive execution of CAPA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly and quarterly metrics.
  • Support all Abbott initiatives as identified by senior management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

  • Bachelor level degree in Engineering, Technical Field, or equivalent.
  • 2-4+ years technical experience.
  • Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, and ISO 13485.
  • Solid communication and interpersonal skills.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • 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 travel approximately 5%.

Preferred Qualifications:

  • Advanced degree in Engineering, Sciences, or related discipline.
  • Medical Device Experience.

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