Quality Engineer
About The Position
The Quality Engineer ensures that products manufactured at the Twinsburg, OH facility are produced and maintained in compliance with applicable regulatory requirements, ISO 13485, and internal Quality Management System (QMS) procedures. This role works closely with Operations, Manufacturing Engineering, Maintenance, and Quality teams to support manufacturing operations, maintain the QMS, facilitate batch record release activities, investigate quality events, support complaint and technical request resolution, and drive continuous improvement initiatives to ensure product quality and regulatory compliance throughout the product lifecycle.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
