2nd shift Quality Engineer II

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

Job summary

Abbott is seeking a 2nd shift Quality Engineer II to support the Minnetonka, MN Electrophysiology division. You will work on qualification, CAPA, and process control initiatives to ensure regulatory compliance and product quality.

The role emphasizes cross-functional teamwork, documentation, and systematic problem solving in a fast-paced medical device environment. Abbott offers strong development and benefits.

Qualifications

• Bachelor’s Degree in engineering or technical field.
• 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.
• Strong verbal and written communications with ability to communicate at multiple levels.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Responsibilities

• Identify and implement effective process control systems to support qualification and ongoing manufacturing.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in development and execution of streamlined business systems to 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.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead and implement Six Sigma and Lean Manufacturing initiatives.
• Lead investigation, resolution and prevention of product and process non-conformances.
• Participate in or lead teams supporting quality disciplines.
• Lead in the completion and maintenance of risk analysis.
• Support Quality Management Systems, Environmental Management Systems, and regulatory requirements.
• Complies with FDA regulations, other regulatory requirements, and company procedures.
• Maintains positive and cooperative communications across all levels.
• Ability to work 2nd shift hours.

Education

Bachelor’s Degree in engineering or Technical Field

Tools

Quality tools/methodologies

FDA/ISO quality systems

Job description

JOB DESCRIPTION: 2nd shift Quality Engineer II Working at Abbott

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.

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.

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.

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.

JOB FAMILY: Operations Quality DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Minnetonka : 14901 DeVeau Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.