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Abbott

Makes heart devices, glucose sensors and lab tests

Principal Quality Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAlameda, CA, USA$114k - $228kIn-person

About the Job

Requirements

  • A Bachelor of Science in Mathematics, Science, or an Engineering discipline is preferred, or an equivalent combination of education and work experience will be considered.
  • At least five years of Quality experience in an FDA- or ISO-regulated environment.

Responsibilities

  • Implement and maintain the effectiveness of the quality system.
  • Use technical depth to understand complaints and improve products and processes to better meet customer needs and reduce issues.
  • Provide guidance on complaint investigation processes and ensure investigations comply with regulations.
  • Set global standards for specifications and drawings that identify and highlight critical quality attributes.
  • Capture complex technical requirements in policies, design plans, and investigations.
  • Translate business strategy into meaningful objectives and day-to-day activities.
  • Anticipate future direction and adjust current processes accordingly.
  • Communicate directional changes effectively and create support for changes.
  • Lead complaint investigations technically and serve as a liaison to Research and Development, Operations, and other Quality functions.
  • Ensure investigation results are appropriately disseminated to relevant subject matter experts.
  • Structure studies and integrate cross-disciplinary and cross-functional issues to determine optimal courses of action, such as investigating processes to meet increasing regulatory requirements while maintaining manufacturing and system construction efficiency.
  • Follow through on project goals, contribute willingly, incorporate others’ ideas, share resources, knowledge, and accountability, participate in team meetings, and serve as a functional subject matter expert or independent technical expert in management reviews.
  • Use project management skills to manage multiple tasks and set priorities to meet business objectives.

Desired Qualifications

  • Demonstrated experience leading teams, organizing and managing projects, and developing, coaching, or guiding team members, including direct or indirect reports.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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