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Quality Assurance Engineer II

4 weeks ago

Brockton, Massachusetts, United States Abbott Full time
About Abbott

Abbott is a global healthcare leader that empowers people to live more fully at all stages of life. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

With a global presence in over 160 countries, our 114,000 colleagues serve people in need. We're committed to delivering innovative solutions that improve patient outcomes and enhance the quality of life.The Opportunity

This role is part of our Electrophysiology division, where we're advancing the treatment of heart disease through breakthrough medical technologies. As the Quality Compliance Engineer II, you'll play a critical role in ensuring our products, processes, and quality records conform to quality standards and establish compliance with our quality system.

You'll work closely with cross-functional teams to facilitate organizational success, protect patient safety, and meet business needs. Your responsibilities will include:

  • Supporting the CAPA Portfolio for the Electrophysiology business through effective project and process mentorship
  • Prioritizing and communicating timelines of individual CAPA projects to facilitate timely completion
  • Processing QA requests, ensuring owners are assigned, and timely responses are provided
  • Leading meetings and communications for QA system information, concerns, and updates
  • Ensuring database and record storage maintenance and integrity for QA systems
  • Supporting execution of CAPA training and identifying continual improvement opportunities within the Abbott CAPA process
  • Driving execution of CAPA data analysis, trending, and reporting
Qualifications

To be successful in this role, you'll need:

  • A Bachelor's degree in Engineering, Technical Field, or equivalent
  • 2-4+ years of technical experience, with 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, with advanced computer skills, including statistical/data analysis and report writing skills
  • Demonstrated 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
About the Role

This position is based in Plymouth, MN, and requires approximately 5% travel. If you're a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply.