Job Description
Location: Buffalo Grove, IL Target Base Pay: $90-$105k/year + 10% bonus Job Summary The Quality Engineer will support quality engineering activities within a regulated laboratory environment focused on medical device testing and validation, including blood-based sample testing. This role partners closely with lab operations, R&D, and quality leadership to ensure compliance, data integrity, and continuous improvement of quality systems and processes. This position will play a key role in strengthening quality systems in support of ongoing regulatory and remediation initiatives. Key Responsibilities Develop and implement inspection, testing, and evaluation methods for laboratory processes and products Establish and maintain sampling plans, data collection methods, and reporting tools for quality and reliability metrics Support nonconforming material processes, including investigation, disposition, and cost-of-quality analysis Partner with lab personnel to ensure proper execution of test methods, data recording, and documentation practices Lead or support root cause investigations and drive corrective and preventive actions (CAPA) to closure Ensure integrity, traceability, and availability of all quality and laboratory data Support internal and external audits, including preparation, execution, and response activities Collaborate with cross-functional teams on product and process qualifications, including validation activities (IQ/OQ/PQ where applicable) Review test results, complaints, and returned product data to identify trends and recommend improvements Develop and deliver training related to quality systems, lab procedures, and compliance requirements Serve as a quality liaison for regulatory interactions and inspections as needed Support continuous improvement initiatives related to lab efficiency, compliance, and data accuracy Required Qualifications Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience) 5-7+ years of Quality Engineering experience 3+ years in medical device, diagnostics, pharmaceutical, or biotechnology environments Strong working knowledge of ISO 13485 and FDA Quality System Regulations Experience with CAPAs, SCARs, and nonconformance (NCMR) processes Familiarity with laboratory testing environments, preferably involving biological or blood sample handling Experience supporting audits and regulatory inspections Preferred Qualifications Experience supporting FDA remediation or quality system improvement initiatives Knowledge of statistical methods for data analysis and process control Certification in Quality Engineering (CQE) or related discipline Experience with validation and qualification of lab equipment and test methods