Bachelor's degree in Engineering, Microbiology, Chemistry, or equivalent work experience (5 years of relevant experience).
Minimum of 1 year experience in Microbiology, Chemistry, or as a Quality Engineer, or 3 years as a Quality Technician.
Experience in a highly regulated environment (medical devices, food, pharmaceuticals, automotive, or aerospace).
Basic statistics knowledge, including Probability and Descriptive statistics.
Familiarity with Six Sigma and Lean Process methodologies.
Responsibilities
Support analytical lab testing for raw materials and products, including microbiological and mechanical testing.
Create and maintain SOPs, Validation and Quality Control Plans, and oversee employee training effectiveness.
Collaborate with QA and Manufacturing to ensure product quality meets applicable standards.
Participate in cross-functional teams for new product and process development.
Assist in the development of medical device products from concept to manufacturing scale-up.
Implement inspection acceptance criteria and sampling plans for production.
Support validation activities for equipment, products, and software.
Benefits
Comprehensive benefits package as outlined in the 2026 Benefits Guide.
Opportunities for professional development and training.
Supportive work environment with a focus on quality and safety.
Full Job Description
Quality Engineer I
Salary Range:$80,000.00 To $85,000.00 annually plus targeted bonus Location: Geneva, IL Bravida Benefits: Click here to view our 2026 Benefits Guide
The Quality Engineer is a part of a Medical Device Manufacturing Quality team and will be responsible for supporting the Quality Management System and providing quality engineering services in support of medical device design, development, production and post-market surveillance activities. This position reports to the Quality Manager.
Strong process development capabilities as well as strong communication skills are essential.
Responsibilities
Support a sophisticated analytical lab for the testing, verification and validation of incoming raw substrate and gray fabrics, intermediate and final products. Laboratory processes include but are not limited to:
Creating and maintaining SOPs, Validation and Quality Control Plans as required; identify training needs and periodically review training effectiveness of employees.
Creating, maintaining, and verifying a robust training system
Creating new and maintaining existing supplier files.
Support the QA, Manufacturing/Operations activities to produce consistent quality of products under applicable quality standards including monthly, quarterly, and annual testing requirements.
Help develop and be the team member of cross-functional teams to create new products, processes and test methods.
Assist with the development of medical device products from concept through development, testing and manufacturing scale-up.
Create and implement inspection acceptance criteria and sampling plans to support production acceptance activity.
Support equipment, product, and software Validation (IQ, OQ, PQ, TMV)
Maintain the Device Master Record (DMR) per product.
Provide engineering support for product quality.
Support and create customer complaint record and assist with the investigation of customer complaints.
Provide support on microbiological, chemical and physical capability studies.
Serve as a member on the Material Review Board (MRB) to disposition non-conforming material.
Generate corrective and preventative actions (CAPA and SCAR) and process owner of follow-up audits to facilitate close-out activities.
Apply statistical problem-solving methods using Minitab.
Adhere to general safety rules, company policies and procedures.
Create and maintain production and QMS matrixes for management review of quality measurables.
Participate in eQMS activities as required.
Requirements
Bachelor's degree in Engineering, Microbiology, Chemistry, or equivalent work experience (5 years of relevant experience).
Minimum of 1 year experience in Microbiology, Chemistry, or as a Quality Engineer, or higher educational levels, or 3 years as a Quality Technician.
Experience functioning in a highly regulated environment such as medical devices, food, pharmaceuticals, automotive, or aerospace.
Basic statistics experience with Probability and Descriptive statistics.
Process development capabilities skills; analytical problem solving.
Six Sigma and Lean Process background.
Experience working in a Clean Room.
Manufacturing experience.
Metrology and Measurement Method Analysis experience.
Must be able to travel up to 5% of the time.
Typical work-related travel assignments range from 3-5 days, and as such overnight, out-of-town stays are required.
Work Environment and Physical Demands
Typical office environment - accommodations will be evaluated where needed.
Other duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
