Quality Engineer - Sturgis, MI Plant
About The Position
The Quality Engineer works at Abbott’s Sturgis, Michigan location in the Abbott Nutrition division. The role develops and maintains quality engineering methodologies and provides quality engineering support for new product development, manufacturing, or systems and services. It supports the development, qualification, and ongoing manufacture of products that meet or exceed internal and external requirements, and helps maintain compliance with FDA, OSHA, Abbott policies and procedures, Quality Management Systems, Environmental Management Systems, and other applicable regulatory requirements. The position leads quality activities and improvement efforts, works with cross-functional teams and personnel at different levels, and applies systematic problem-solving, experimentation, process control, risk analysis, and product verification and validation. The posted base pay range is $61,300 to $122,700; pay may vary in specific locations. The position has no travel requirement.
Requirements
- Bachelor’s degree and 2–5 years of relevant experience in Quality Assurance, Manufacturing, or Engineering; or a master’s degree and 1–3 years of relevant experience in those fields.
- Demonstrated use of quality tools and methodologies.
- Detailed knowledge of FDA requirements and GMP.
- Strong project management and leadership skills.
- Advanced computer skills, including statistical and data analysis and report writing.
- Ability to implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing.
- Ability to leverage or engage others to accomplish projects.
- Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
- Ability to multitask, prioritize, and meet deadlines in a timely manner.
Nice To Haves
- Experience working in a broader enterprise or cross-division business unit model.
- ASQ Certified Quality Engineering Certificate.
Responsibilities
- Develop and maintain quality engineering methodologies and provide quality engineering support for new product development, manufacturing, or system/services support.
- Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing.
- Lead, coach, and mentor non-exempt and entry-level exempt personnel.
- Assist in developing and executing business systems that identify and resolve quality issues.
- Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve quality issues.
- Design and conduct experiments for process optimization or improvement, and document plans and results, including protocols and reports.
- Lead process control and monitoring of critical-to-quality parameters and specifications.
- Lead and implement product and process improvement methods, including Six Sigma and Lean Manufacturing.
- Lead investigation, resolution, and prevention of product and process nonconformances.
- Participate in or lead teams supporting quality disciplines, decisions, and practices, including serving as a Quality function Core Team Member.
- Lead completion and maintenance of risk analyses.
- Work with design engineering on product verification and validation.
- Work with microbiology to ensure appropriate environmental monitoring and consideration of microbiology requirements in product and process development.
- Support divisional initiatives and compliance with QMS, EMS, and other regulatory requirements.
- Meet compliance standards, including FDA, OSHA, and Abbott policies and procedures.
Benefits
- Medical, dental, and vision coverage, wellness and occupational health programs; medical benefits start on day one.
- 120 hours of accrued vacation in the first year, prorated as applicable, a vacation buy program, three personal days, and ten paid holidays.
- Retiree healthcare program.
- 401(k) retirement savings plan with a company match.
- Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
- Financial security through competitive compensation, incentives, and a retirement plan.
- Free coverage in the HIP PPO medical plan for eligible participants who complete a short wellness assessment, applicable in the next calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
