Quality Engineer - Lab Operations
Employment Type:
Permanent
Job Category: Quality Engineering
Job Number: 56072357
Compensation: $85000-105000 / year
Job Description
Quality Engineer – Lab Operations
Location: Buffalo Grove, IL
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.
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
Meet Your Recruiter
Max Francis
Recruiting Team Lead
Max Francis is a Recruiter at Sterling Engineering, where he has been a valued member of the team for more than seven years. He focuses on supporting a key Flex account, helping connect qualified candidates with opportunities that align with their experience, goals, and long-term career path.
Max understands that making a career move is a major life decision. He enjoys helping candidates navigate the ever-changing job market and hiring process with confidence, clarity, and support. His goal is to help each candidate take the next meaningful step in their career while finding the right long-term professional home.
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Looking to kickstart your career in the vibrant area surrounding Buffalo Grove, Illinois? Explore our job opportunities in this thriving community where endless growth opportunities await. Nestled in the heart of Lake County, this charming suburb offers a perfect blend of urban amenities and picturesque natural beauty. With renowned art galleries like the Buffalo Creek Art Center, dynamic theaters such as the Metropolis Performing Arts Centre, and easy access to professional sports teams like the Chicago Bears, there's something for everyone here. Indulge in local delicacies like deep dish pizza and Chicago-style hot dogs, then unwind at the beautiful Buffalo Creek Forest Preserve. Join us in Buffalo Grove, IL, and let your career flourish in this captivating location!