Quality Engineer II

Abbott; Minnetonka (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

HIP medical plan

Tuition reimbursement

Retirement plan

Job summary

Abbott in Minnetonka, MN is seeking a Quality Engineer II to sustain and improve quality of electrophysiology products, ensuring manufacturing processes meet daily production schedules and regulatory requirements.

You will lead CAPA, risk analysis, and cross-functional collaboration to protect patient safety and support product quality. This role emphasizes problem solving and data-driven decisions in a fast-paced, matrixed environment.

Qualifications

• Bachelor’s Degree in engineering or technical field or equivalent
• 2–5 years engineering experience with quality tools/methodologies
• FDA, GMP, ISO 13485, ISO 14971 knowledge
• Ability to work in a matrixed, diverse environment
• Strong written and verbal communication skills
• Multitasks and meets deadlines
• Attention to detail and organizational skills

Responsibilities

• Identify and implement process control systems for qualification and manufacturing
• Lead in implementing assurances, process controls, and CAPA systems
• Develop and execute streamlined business systems to identify and resolve quality issues
• Apply systematic problem-solving to quality issues
• Collaborate with cross-functional teams to design experiments for process optimization
• Document experiment plans and results (protocols and reports)
• Lead process control and monitoring of CTQ parameters
• Lead product/process improvement methodologies (Six Sigma/Lean)
• Investigate and prevent non-conformances
• Support quality disciplines and act as Core Team Member
• Lead risk analysis completion and maintenance
• Support QMS/EMS and regulatory initiatives
• Maintain positive cross-level communications and collaboration

Skills

Communication

Time management

Attention to detail

Team player

Problem solving

Education

Bachelor’s degree in engineering/technical field

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 115,000 colleagues serve people in more than 160 countries.

Quality Engineer II

Working at Abbott

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, the 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 Opportunity

This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the 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 assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Work On

• Identify and implement effective process control systems to support the qualification, and on-going 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 which effectively identify and resolve quality issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work with cross functional teams to 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 non-conformances.
• 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees.

Required Qualifications

• Bachelor’s Degree in engineering or Technical Field or an equivalent combination of education and work experience
• 2-5 years Engineering experience and demonstrated use of quality tools/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 communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes, and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.