Quality Engineer - Sturgis, MI, South Bend

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.

Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. 

Join our Abbott Nutrition team in Sturgis, MI — a facility with over 70 years of history in delivering essential nutrition to families worldwide. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others. 

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

Production areas that are clean, well-lit and temperature-controlled  

Training and career development, with onboarding programs for new employees and tuition assistance  

Financial security through competitive compensation, incentives and retirement plan 

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1 

Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays 

Retiree Healthcare program 

Robust 401(k) retirement savings with a generous company match 

Tuition reimbursement, the student debt program and 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 stable company with a record of strong financial performance and history of being actively involved in local communities 

A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.  

What You’ll Work On: 

The Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

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)

Support and/or lead investigation, resolution and prevention of product and process nonconformances

Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.

Develop preventive measures to avoid recurrence.

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

Analyze and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management.

Participate in internal and external audits, providing necessary documentation and support.

Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

Bachelor’s Degree plus 2-5 years of relevant experience in Quality Assurance, Manufacturing or Engineering experience OR Master's Degree plus 1-3 years of relevant experience in Quality Assurance, Manufacturing or Engineering

In-depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and the application of statistical methods.

Experience with CAPA processes.

Demonstrated use of Quality tools/methodologies.

Detailed knowledge of FDA, GMP

Strong project management and leadership skills

Advanced computer skills, including statistical/data analysis and report writing skills. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Preferred Qualifications

Experience working in a broader enterprise/cross-division business unit model

ASQ Certified Quality Engineering Certificate

The base pay for this position is $60,000.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.