Lead Quality Assurance Engineer

2 weeks ago

Minnetonka, Minnesota, United States Abbott Full time

About Abbott

Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutrition, and branded generic medications. With a workforce of 114,000 professionals, we serve communities in over 160 nations.

Our Commitment

At Abbott, we are committed to pioneering innovative scientific solutions that advance health outcomes. We continuously look ahead, anticipating shifts in medical science and technology.

Why Join Abbott?

At Abbott, you will engage in meaningful work, experience personal and professional growth, and enjoy a fulfilling life. We offer:

  • Career advancement opportunities within a global organization.
  • Comprehensive medical benefits for employees through our Health Investment Plan (HIP) PPO.
  • A robust retirement savings program with significant employer contributions.
  • Tuition reimbursement and educational benefits to support your academic pursuits.
  • A workplace recognized globally as a top employer and celebrated by Fortune as one of the most admired companies.

Position Overview

This role is situated within our Cardiac Rhythm Management division.

As a leader in Cardiac Rhythm Technologies, we are dedicated to developing innovative solutions that enhance the treatment of heart rhythm disorders.

The Lead Quality Assurance Engineer will oversee supplier selection, evaluation, material qualification, supplier performance, and inspection processes. This role is crucial in establishing and maintaining quality engineering practices that comply with both company and regulatory standards.

Key Responsibilities

  • Develop and refine division supplier quality program policies and procedures.
  • Provide mentorship and guidance to technical team members, including engineers and technicians.
  • Support Purchasing, R&D, Manufacturing, and Quality engineers in implementing program requirements.
  • Review and approve product drawings and quality plans from suppliers.
  • Oversee the creation of inspection procedures and first article requirements for supplied products.
  • Offer engineering support to the Receiving Inspection team, including statistical analysis and measurement techniques.
  • Evaluate supplier capabilities through audits, technical discussions, and testing.
  • Communicate quality concerns to suppliers through audits and corrective action requests.
  • Participate in Non-Conforming Material Reviews for supplied products.
  • Engage in supplier performance evaluations and development of partnerships.
  • Utilize engineering analysis to minimize inspection needs in line with program policies.
  • Collaborate with Manufacturing engineering to resolve product-related issues.
  • Employ systematic problem-solving techniques to address quality challenges.
  • Design and conduct experiments aimed at process enhancement.
  • Lead teams in fulfilling Supplier Development Quality program requirements.
  • Facilitate supplier audits and quality improvement initiatives.
  • Adhere to U.S. Food and Drug Administration (FDA) regulations and company policies.

Qualifications

  • Bachelor's degree in Engineering or a related technical field, or equivalent experience.
  • Master's degree is preferred.
  • A minimum of 5 years of relevant experience, preferably in the medical device sector.
  • Demonstrated supervisory experience and proficiency in quality tools and methodologies.
  • In-depth knowledge of FDA regulations, GMP, ISO 13485, and ISO standards.
  • Strong communication and interpersonal skills, with proven project management capabilities.
  • Advanced computer skills, including statistical analysis and report writing.
  • Experience with process improvement methodologies such as Six Sigma and Lean Manufacturing.
  • Ability to work effectively in a diverse and dynamic environment.
  • Willingness to travel as necessary.

Join Abbott to explore diverse career opportunities and contribute to a company that values your growth and well-being.

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