Quality Engineer I

Argentum Medical•Geneva, IL

9d•$80,000 - $85,000

About The Position

The Quality Engineer I is part of a medical device manufacturing Quality team and supports the Quality Management System, providing quality engineering services for medical device design, development, production, and post-market surveillance. The position reports to the Quality Manager. Strong process development capabilities and communication skills are essential. The role supports an analytical laboratory that tests, verifies, and validates incoming raw substrates and gray fabrics, as well as intermediate and finished products. Laboratory work includes atomic absorption, titration and pH, microbiological, mechanical, chemical, and environmental monitoring tests. The Quality Engineer also supports Quality Assurance and Manufacturing/Operations in producing consistent products under applicable quality standards. The position contributes to product and process development, validation, inspection planning, product quality engineering, complaint investigations, nonconforming-material disposition, corrective and preventive actions, statistical problem-solving, and quality-system documentation and monitoring. The role requires up to 5% travel, including occasional overnight stays for typical 3–5 day assignments. The work environment is a typical office environment; accommodations will be evaluated where needed.

Requirements

Bachelor’s degree in Engineering, Microbiology, Chemistry, or equivalent work experience (5 years of relevant experience).
At least 1 year of experience in Microbiology, Chemistry, or as a Quality Engineer, or higher educational levels, or 3 years as a Quality Technician.
Experience working in a highly regulated environment such as medical devices, food, pharmaceuticals, automotive, or aerospace.
Basic statistics experience, including probability and descriptive statistics.
Process development capabilities and analytical problem-solving skills.
Six Sigma and Lean Process background.
Experience working in a clean room.
Manufacturing experience.
Metrology and Measurement Method Analysis experience.
Ability to travel up to 5% of the time, including overnight, out-of-town stays for typical 3–5 day assignments.

Responsibilities

Support analytical laboratory testing, verification, and validation of incoming raw substrates and gray fabrics, intermediate products, and final products, including atomic absorption, titration and pH, microbiological, mechanical, chemical, and environmental monitoring tests.
Create and maintain SOPs, validation plans, and quality control plans; identify training needs and periodically review employee training effectiveness.
Create, maintain, and verify a robust training system.
Create new supplier files and maintain existing supplier files.
Support QA and Manufacturing/Operations activities to produce consistent-quality products under applicable quality standards, including monthly, quarterly, and annual testing requirements.
Help develop and participate in cross-functional teams creating new products, processes, and test methods.
Assist with medical device product development from concept through development, testing, and manufacturing scale-up.
Create and implement inspection acceptance criteria and sampling plans for production acceptance.
Support equipment, product, and software validation, including IQ, OQ, PQ, and TMV.
Maintain the Device Master Record (DMR) for each product.
Provide engineering support for product quality.
Create and support customer complaint records and assist with complaint investigations.
Support microbiological, chemical, and physical capability studies.
Serve on the Material Review Board (MRB) to disposition nonconforming material.
Generate corrective and preventive actions (CAPA and SCAR) and serve as process owner for 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 matrices for management review of quality measures.
Participate in eQMS activities as required.
Travel up to 5% of the time; typical assignments are 3–5 days and require overnight, out-of-town stays.