2nd shift Quality Engineer II

A global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries with 115,000 colleagues.

About the role

This position is based in our Minnetonka, MN location within the Electrophysiology division. As the 2nd shift Quality Engineer II, you’ll support sustainability of commercially released product, ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will ensure all products conform to established compliance requirements within Abbott’s Quality Management System and maintain strong collaborative partnerships with cross-functional teams to protect patient/user safety and meet business needs.

Second shift schedule: Monday - Thursday, 2:30 PM - 12:30 AM CST with occasional overtime on Fridays.

Responsibilities

• Identify and implement effective process control systems to support qualification and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Assist in the development and execution of streamlined business systems to identify and resolve quality issues.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Work with cross-functional teams to design and conduct experiments for process optimization and improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead and implement product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Lead the investigation, resolution, and prevention of product and process non-conformances.
• Participate in or lead teams supporting quality disciplines, decisions, and practices (e.g., represent Quality as a Core Team Member).
• Lead in the completion and maintenance of risk analysis.
• Support Company initiatives related to 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, and operating procedures.
• Maintain positive and cooperative communications and collaboration with all levels of employees.

Requirements

• Bachelor’s Degree in engineering or a technical field, or an equivalent combination of education and work experience.
• 2-5 years of engineering experience with demonstrated use of quality tools and methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• 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.
• Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

• Prior medical device experience.
• Experience as a CAPA owner or key cross-functional team member leading a CAPA.

Benefits

• Career development with an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan (eligibility in the next calendar year).
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit for affordable bachelor’s degree paths.
• Recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune.
• Recognized as a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Schedule

Monday - Thursday, 2:30 PM - 12:30 AM CST with occasional overtime on Fridays.