Quality Engineer (Arlington Heights)
Sterling Engineering, Arlington Heights, IL, United States
Quality Engineer
Location:
Arlington Heights, IL
Reports to:
Quality Engineering Manager
Job Summary
The Quality Engineer is responsible for maintaining and improving quality engineering processes, systems, and standards across the organization. This role plays a key part in ensuring product quality, regulatory compliance, and continuous improvement initiatives.
Key Responsibilities
Develop and implement inspection, testing, and evaluation methods to ensure product quality and reliability
Design sampling procedures and create documentation for recording, analyzing, and reporting quality data
Establish and manage processes for disposition of nonconforming materials, including cost impact assessment
Lead and support product testing activities, including data collection and analysis related to materials, processes, and product performance
Create training materials and conduct training sessions on quality systems and procedures
Partner with Product Engineers and Quality Program Managers to support customer-related quality issues
Ensure accuracy, integrity, and availability of quality data; compile and report on quality metrics
Initiate, track, and drive corrective actions (CAPAs) to completion
Support internal and external quality audits, including preparation and follow-up activities
Develop, implement, and maintain quality standards for manufacturing processes and finished products
Design and improve methods for evaluating product and equipment precision and accuracy
Investigate quality issues, including returned products, and recommend corrective actions
Establish programs to evaluate production and measurement equipment performance
Approve product, process, and equipment qualifications
Serve as a liaison with regulatory agencies as needed
Qualifications
Bachelor’s degree in Engineering or a related field (or equivalent experience)
Minimum of 6 years of experience in quality engineering
At least 3 years of experience in the medical device, pharmaceutical, or biotechnology industry
Wet lab experience is needed (Pharma, Med Device, Life Science, Health Care.)
Strong knowledge of ISO 13485 standards
Experience with quality systems and processes such as CAPA, SCAR, and NCMR
Familiarity with FDA and ISO regulatory requirements (certifications preferred)
What We Offer
Comprehensive medical, dental, and vision insurance
Life insurance coverage
Short-term and long-term disability benefits
401(k) with company match
Paid vacation and sick time
Tuition reimbursement
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Location:
Arlington Heights, IL
Reports to:
Quality Engineering Manager
Job Summary
The Quality Engineer is responsible for maintaining and improving quality engineering processes, systems, and standards across the organization. This role plays a key part in ensuring product quality, regulatory compliance, and continuous improvement initiatives.
Key Responsibilities
Develop and implement inspection, testing, and evaluation methods to ensure product quality and reliability
Design sampling procedures and create documentation for recording, analyzing, and reporting quality data
Establish and manage processes for disposition of nonconforming materials, including cost impact assessment
Lead and support product testing activities, including data collection and analysis related to materials, processes, and product performance
Create training materials and conduct training sessions on quality systems and procedures
Partner with Product Engineers and Quality Program Managers to support customer-related quality issues
Ensure accuracy, integrity, and availability of quality data; compile and report on quality metrics
Initiate, track, and drive corrective actions (CAPAs) to completion
Support internal and external quality audits, including preparation and follow-up activities
Develop, implement, and maintain quality standards for manufacturing processes and finished products
Design and improve methods for evaluating product and equipment precision and accuracy
Investigate quality issues, including returned products, and recommend corrective actions
Establish programs to evaluate production and measurement equipment performance
Approve product, process, and equipment qualifications
Serve as a liaison with regulatory agencies as needed
Qualifications
Bachelor’s degree in Engineering or a related field (or equivalent experience)
Minimum of 6 years of experience in quality engineering
At least 3 years of experience in the medical device, pharmaceutical, or biotechnology industry
Wet lab experience is needed (Pharma, Med Device, Life Science, Health Care.)
Strong knowledge of ISO 13485 standards
Experience with quality systems and processes such as CAPA, SCAR, and NCMR
Familiarity with FDA and ISO regulatory requirements (certifications preferred)
What We Offer
Comprehensive medical, dental, and vision insurance
Life insurance coverage
Short-term and long-term disability benefits
401(k) with company match
Paid vacation and sick time
Tuition reimbursement
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.