Quality Engineer

About SaniSure

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines.

As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

Job Summary

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.

Essential Functions

• 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.

Education

• Bachelor's degree in Business, Sciences or Engineering or a related technical field.

Required Experience & Competencies

• 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.

Equal Employment Opportunity Policy

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.