Senior Quality Engineer

JOB DESCRIPTION

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. Our 114,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, Freedom 2 Save student debt program and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Sr. Quality Engineer position works onsite of our Minnetonka, MN location in the Abbott CRM Division. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

• List the main responsibilities this role regularly performs.
  • Identify and implement effective process control systems to support the development, qualification, and on‑going manufacturing of products to meet or exceed internal and external requirements.
  • Lead, coach, and mentor non‑exempt and entry level exempt personnel.
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Design and conduct experiments for process optimization and/or improvement.
  • Appropriately document experiment plans and results, including protocol writing and reports.
  • Lead process control and monitoring of CTQ parameters and specifications.
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Lead the investigation, resolution and prevention of product and process nonconformances.
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
  • Lead in the completion and maintenance of risk analysis.
  • Work with design engineering in the completion of product verification and validation.
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
  • 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.
  • Performs other related duties and responsibilities, on occasion, as assigned.

• Bachelors Degree (± 16 years) in an Engineering or Technical Field or an equivalent combination of education and work experience.
  • Experience/Background
    • Minimum 5 years.
    • Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid communication and interpersonal skills. Strong project management and leadership skills, including the demonstrated ability to lead multi‑departmental project teams and resolve quality‑related issues in a timely and effective manner.
    • Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred.…