2nd shift Quality Engineer II

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

Benefits offered by this job

Free medical coverage

Competitive retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott in Minnetonka, MN is seeking a 2nd shift Quality Engineer II to support the Electrophysiology product line. You will ensure manufacturing processes meet schedules while improving productivity and product quality, and you will uphold FDA, GMP, ISO requirements.

The role requires collaboration with cross-functional teams, CAPA ownership, and risk analysis. The shift is Monday–Thursday 2:30 PM–12:30 AM CST with occasional overtime on Fridays, and Abbott offers strong benefits, tuition

Qualifications

• Bachelor's degree in engineering or equivalent.
• 2-5 years of engineering experience with FDA, GMP, ISO 13485 and ISO 14971 knowledge.
• Ability to work in a matrixed, fast-paced environment.

Responsibilities

• Identify and implement effective process controls to support qualification and ongoing manufacturing.
• Lead CAPA systems to meet internal and external requirements.
• Develop and execute streamlined systems to identify and resolve quality issues.
• Apply systematic problem-solving to prioritize and resolve quality issues.
• Collaborate with cross-functional teams to design experiments for process optimization.
• Document experiment plans and results, including protocol writing and reports.
• Lead risk analysis and monitor CTQ parameters.
• Support quality disciplines and regulatory requirements.

Skills

Quality tools

Process improvement

CAPA

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering or Technical Field

Tools

CAPA

Six Sigma

Lean Manufacturing

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.

2nd shift 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 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 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.

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

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
• Ability to work 2nd shift hours

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.