NPAworldwide
Job Description
About the Role
The Quality Engineer serves as a key quality and regulatory resource within an FDA-regulated manufacturing environment. This role partners closely with manufacturing, inspection, and customer-facing teams to ensure products consistently meet internal specifications, customer requirements, and applicable regulatory standards. The Quality Engineer leads continuous improvement initiatives, supports product and process lifecycle activities, and ensures compliance with FDA Quality System Regulations, sterilization standards, and cleanroom requirements.
Key Responsibilities Quality Engineering & Continuous Improvement
Lead continuous improvement initiatives within assigned manufacturing areas using data-driven analysis.
Perform root cause analysis and implement corrective and preventive actions (CAPA) in alignment with FDA expectations.
Review, investigate, and disposition nonconforming product in accordance with established quality procedures.
Product & Process Lifecycle Management
Support the full product lifecycle from introduction through sustained production, including design transfer, process qualification, validation, and ongoing process monitoring.
Develop and maintain control plans, qualification protocols (IQ/OQ/PQ), and risk-based quality documentation to minimize scrap and prevent customer returns.
Ensure change management activities are properly evaluated, documented, and approved throughout the product lifecycle.
Regulatory Compliance, Sterilization & Cleanroom Oversight
Verify that manufacturing instructions, SOPs, and quality records comply with customer requirements and FDA regulations, including 21 CFR Part 820.
Support sterilization and cleanroom-controlled manufacturing processes in compliance with FDA and applicable ISO standards.
Ensure validation activities meet FDA expectations for special processes, including sterilization.
Cross-Functional Support & Training
Support quality inspectors and technicians by developing, maintaining, and explaining procedures, work instructions, and quality standards.
Partner with manufacturing, production, and customer service teams to resolve quality issues and maintain regulatory alignment.
Qualifications Education
Bachelors degree in Engineering, Quality, Life Sciences, or a related technical field
High School Diploma or GED with equivalent progressive experience in regulated manufacturing
Experience
2+ years of quality engineering experience in a manufacturing environment
5+ years of progressive experience in a regulated manufacturing environment
Experience working independently in production-driven environments
Technical Skills
Working knowledge of FDA Quality System Regulations (21 CFR Part 820)
Experience supporting product and process validation activities (IQ/OQ/PQ)
Proficiency with SPC, statistical analysis, and quality data tools
Ability to read and interpret technical drawings, blueprints, SOPs, and regulatory documentation
Strong computer skills, including quality systems and data analysis tools
Certifications (Preferred)
Six Sigma Green Belt or Black Belt
Audit support experience (FDA, notified body, or customer audits)
Soft Skills
Strong attention to detail and accuracy
Excellent problem-solving and analytical skills
Ability to manage multiple priorities in a dynamic manufacturing environment
Clear written and verbal communication across technical and non-technical audiences
Collaborative mindset with strong cross-functional engagement skills
Standards & Regulations Commonly Applied (Preferred)
FDA 21 CFR Part 820 (QSR), including:
820.30 Design Controls
820.70 Production and Process Controls
820.75 Process Validation
820.90 Nonconforming Product
820.100 Corrective and Preventive Action (CAPA)
ISO 13485 Medical device quality management systems
ISO 11135 Ethylene Oxide (EO) sterilization
ISO 11137 Radiation sterilization
ISO 17665 Moist heat (steam) sterilization
ISO 14644 Cleanrooms and controlled environments
Why Is This a Great Opportunity Why Join Us? Join a regulated manufacturing organization where quality and compliance are core to operational success.
Play a critical role in product lifecycle management, sterilization oversight, and continuous improvement.
Work cross-functionally with engineering, manufacturing, and customer teams in a hands-on environment.
Opportunity to deepen expertise in FDA, ISO, and cleanroom-controlled manufacturing processes.
#J-18808-Ljbffr
Key Responsibilities Quality Engineering & Continuous Improvement
Lead continuous improvement initiatives within assigned manufacturing areas using data-driven analysis.
Perform root cause analysis and implement corrective and preventive actions (CAPA) in alignment with FDA expectations.
Review, investigate, and disposition nonconforming product in accordance with established quality procedures.
Product & Process Lifecycle Management
Support the full product lifecycle from introduction through sustained production, including design transfer, process qualification, validation, and ongoing process monitoring.
Develop and maintain control plans, qualification protocols (IQ/OQ/PQ), and risk-based quality documentation to minimize scrap and prevent customer returns.
Ensure change management activities are properly evaluated, documented, and approved throughout the product lifecycle.
Regulatory Compliance, Sterilization & Cleanroom Oversight
Verify that manufacturing instructions, SOPs, and quality records comply with customer requirements and FDA regulations, including 21 CFR Part 820.
Support sterilization and cleanroom-controlled manufacturing processes in compliance with FDA and applicable ISO standards.
Ensure validation activities meet FDA expectations for special processes, including sterilization.
Cross-Functional Support & Training
Support quality inspectors and technicians by developing, maintaining, and explaining procedures, work instructions, and quality standards.
Partner with manufacturing, production, and customer service teams to resolve quality issues and maintain regulatory alignment.
Qualifications Education
Bachelors degree in Engineering, Quality, Life Sciences, or a related technical field
High School Diploma or GED with equivalent progressive experience in regulated manufacturing
Experience
2+ years of quality engineering experience in a manufacturing environment
5+ years of progressive experience in a regulated manufacturing environment
Experience working independently in production-driven environments
Technical Skills
Working knowledge of FDA Quality System Regulations (21 CFR Part 820)
Experience supporting product and process validation activities (IQ/OQ/PQ)
Proficiency with SPC, statistical analysis, and quality data tools
Ability to read and interpret technical drawings, blueprints, SOPs, and regulatory documentation
Strong computer skills, including quality systems and data analysis tools
Certifications (Preferred)
Six Sigma Green Belt or Black Belt
Audit support experience (FDA, notified body, or customer audits)
Soft Skills
Strong attention to detail and accuracy
Excellent problem-solving and analytical skills
Ability to manage multiple priorities in a dynamic manufacturing environment
Clear written and verbal communication across technical and non-technical audiences
Collaborative mindset with strong cross-functional engagement skills
Standards & Regulations Commonly Applied (Preferred)
FDA 21 CFR Part 820 (QSR), including:
820.30 Design Controls
820.70 Production and Process Controls
820.75 Process Validation
820.90 Nonconforming Product
820.100 Corrective and Preventive Action (CAPA)
ISO 13485 Medical device quality management systems
ISO 11135 Ethylene Oxide (EO) sterilization
ISO 11137 Radiation sterilization
ISO 17665 Moist heat (steam) sterilization
ISO 14644 Cleanrooms and controlled environments
Why Is This a Great Opportunity Why Join Us? Join a regulated manufacturing organization where quality and compliance are core to operational success.
Play a critical role in product lifecycle management, sterilization oversight, and continuous improvement.
Work cross-functionally with engineering, manufacturing, and customer teams in a hands-on environment.
Opportunity to deepen expertise in FDA, ISO, and cleanroom-controlled manufacturing processes.
#J-18808-Ljbffr