Quality Engineer

Sol-Millennium is a global healthcare company dedicated to improving the safety and well‑being of patients and healthcare providers. With innovative solutions and a commitment to excellence, we strive to deliver products that enhance the quality of care. Our team is passionate, driven, and committed to making a difference in the healthcare industry.

We are seeking a Quality Engineer to join our team in Chicago. This role will support quality engineering activities across new product development, post‑market surveillance, customer‑facing quality needs, CAPA/NCR management, and regulatory audit readiness. The ideal candidate has hands‑on medical device quality experience and is comfortable working cross‑functionally in a fast‑paced, regulated environment.

• Develop and execute test plans and product evaluation protocols for new products, including drug delivery and sterile medical devices, ensuring compliance with performance specifications, sterilization validation requirements, and global regulatory standards.
• Support customer‑facing quality activities, including responses to tenders, technical questionnaires, and quality agreements, ensuring alignment with regulatory and product requirements.
• Support Quality and Regulatory requirements for new product development, including specification development and integration of post‑market data throughout the product lifecycle.
• Contribute to post‑market surveillance activities, including complaint handling, adverse event reporting, field corrective actions, and product testing.
• Collaborate cross‑functionally with Quality, Regulatory Affairs, R&D, Operations, and Sourcing to support compliant and efficient processes across product development and lifecycle management.
• Own and drive CAPA and NCR processes, including investigation, root cause analysis, corrective action implementation, and timely closure in compliance with quality system requirements.
• Support medical device audits and regulatory inspections, including ISO 13485, MDSAP, and FDA audits, through preparation, documentation review, and response coordination.

• Bachelor’s degree in Engineering or a related technical discipline.
• 3‑5+ years of quality engineering experience in the medical device industry.
• Proven experience owning CAPA and NCR processes, including investigation, root cause analysis, corrective action implementation, and closure.
• Hands‑on experience with post‑market surveillance and new product development, including design controls and verification/validation.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and ISO 14971 risk management.
• Experience supporting audits and inspections, including ISO 13485, MDSAP, and FDA.
• Strong analytical, problem‑solving, documentation, and cross‑functional collaboration skills.
• Ability to work independently in a dynamic and fast‑paced environment.

• Experience with sterile medical devices, drug delivery products, or combination‑product‑adjacent quality requirements.
• Experience supporting global regulatory or customer quality documentation.
• Strong understanding of product lifecycle quality requirements, including complaint trends, risk management, and continuous improvement.

The salary range for this role is $85,000 – $100,000 annually
. Actual compensation will be determined based on factors such as relevant experience, skills, qualifications, internal equity, and business needs.

Sol-Millennium offers a comprehensive benefits package, including medical, dental, vision, retirement savings, paid time off, and other company‑sponsored benefits, subject to plan terms and eligibility.

Sol-Millennium is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other status protected by applicable law.

We are committed to maintaining a respectful and inclusive workplace and evaluating candidates based on their qualifications, experience, and ability to perform the responsibilities of the role.