Quality Engineer Jobs

About The Position

Requirements

• Bachelor's degree in Business, Sciences or Engineering or a related technical field.
• 3–6 years of Quality Engineering experience within the medical device, pharmaceutical, biotechnology, or combination product industry.
• Working knowledge and practical experience with ISO 13485 Quality Management Systems.
• Strong understanding of quality systems including CAPA, nonconformance management, change control, document control, and product release activities.
• Strong statistical analysis skills including sampling plans, process capability, hypothesis testing, SPC, and Cpk/Ppk analysis.
• Strong root cause analysis and problem-solving skills utilizing methodologies such as 8D, Fishbone Diagrams, and 5-Why.
• Demonstrated ability to drive continuous improvement through collaboration, data analysis, and cross-functional teamwork.
• Excellent written and verbal communication skills with the ability to work effectively across multiple functional areas.
• Strong technical writing skills with experience developing and maintaining controlled documentation.
• Proficiency with Microsoft Office applications.

Responsibilities

• Support root cause investigations, CAPA, and nonconformance activities related to design, manufacturing, and process issues.
• Collaborate with Operations and Engineering to resolve quality issues affecting production and product transfers.
• Support internal, customer, and ISO audits as a Quality subject matter expert and participate in the implementation of corrective actions resulting from audit findings.
• Identify and drive continuous improvement initiatives related to extrusion processes, improving product quality, reducing scrap, and optimizing manufacturing performance.
• Maintain current knowledge of evolving regulatory requirements and industry standards applicable to the Twinsburg product portfolio.
• Author, review, revise, and approve SOPs, work instructions, quality records, and other controlled documentation.
• Investigate nonconformances, deviations, manufacturing issues, and customer complaints using structured problem-solving methodologies including 8D, 5-Why, and Fishbone analysis.
• Manage Corrective and Preventive Action (CAPA) investigations, implementation activities, and effectiveness checks.
• Participate in the investigation, review, and disposition of nonconforming materials, deviations, change controls, and manufacturing quality events.
• Support Manufacturing Quality Assurance activities by evaluating process controls and recommending improvements to ensure consistent product quality and compliance.
• Monitor quality metrics and statistical trends to identify opportunities for process improvement and risk reduction.
• Assist with implementation of quality system changes and provide training or guidance on quality procedures, documentation, and Good Documentation Practices (GDP), as needed.
• Perform other duties as assigned.