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Quality Engineer - Lab Operations

Sterling Engineering, Inc.

Buffalo Grove, IL

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Certified Quality Engineer (CQE), Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Collection, Data Quality, Documentation, Engineering, External Audit, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Internal Audit, Laboratory Analysis, Laboratory Equipment, Laboratory Operations, Laboratory Techniques, Laboratory Testing, Leadership, Maintain Compliance, Medical Diagnosis, Medical Equipment, Medical Tests, Process Control Engineering, Process Validation, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, Sample/Specimen Processing, Statistics, Traceability, Training/Teaching, Trend Analysis, Validation Testing
LOCATION
Buffalo Grove, IL
POSTED
19 days ago
Quality Engineer – Lab Operations
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

About the Company

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Sterling Engineering, Inc.

Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:

 

  • Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.

 

  • Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.

 

Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1969
WEBSITE
http://www.sterling-engineering.com

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