Job SummaryThe Quality Engineer - Design Quality Assurance and Sterilization is responsible for ensuring quality and regulatory compliance throughout new product development, product transfers into manufacturing, and the company's global sterilization program. This role partners cross-functionally with Engineering and to ensure products are designed, validated, and launched in full compliance with ISO 13485, ISO 11137 and other applicable regulatory and quality standards.
Essential FunctionsDesign Quality Assurance- Serve as the Quality representative on cross-functional new product development (NPD) teams, ensuring design control requirements are met throughout the product lifecycle
- Author, review, and approve design control deliverables including design inputs/outputs, risk management files (per ISO 14971), design verification/validation protocols and reports, and design history files (DHF)
- Lead or support Failure Mode and Effects Analyses (dFMEA)
- Support design transfer activities, ensuring manufacturing processes are robust and capable of consistently producing product that meets specifications
- Review and approve engineering changes and assess impact on product quality and validated states
- Support root cause investigations, CAPA, and nonconformance activities tied to design or process issues
Sterilization Program Management- Own and maintain the global sterilization program, including validation, revalidation, and dose audits for applicable modalities (gamma)
- Ensure ongoing compliance with ISO 11137 and other relevant sterilization standards
- Manage relationships with contract sterilization providers/labs, including audits and performance monitoring
- Monitor sterility assurance levels (SAL), bioburden trends, and environmental monitoring data
- Lead or support sterilization-related change assessments and ensure timely revalidation when processes, materials, or packaging change
Cross-Functional Partnership & Compliance- Collaborate with Operations and Engineering to resolve quality issues affecting production and product transfers
- Support internal and external audits (Customer, ISO) as a subject matter expert for design and sterilization records
- Identify and drive continuous improvement initiatives related to design controls and sterilization processes
- Maintain current knowledge of evolving regulatory requirements and industry standards
Education / Certifications- Bachelor's degree in biological sciences, engineering, or a related field.
Required Experience & CompetenciesEducation & Experience- 3-6 years of experience in Quality Engineering, Design Assurance, or R&D within the medical device, pharmaceutical, or combination product industry
- Direct experience with sterilization validation (gamma) strongly preferred
Knowledge, Skills & Abilities- Working knowledge of FDA 21 CFR 820 (QSR), ISO 13485, ISO 14971, and sterilization standards (ISO 11135/11137/17665)
- Experience with design control processes and documentation (DHF, DMR, risk management)
- Statistical analysis skills (sampling plans, process capability, hypothesis testing)
- Strong root cause analysis and problem-solving skills (8D, fishbone, 5-Why)
- Excellent written and verbal communication skills; ability to work cross-functionally
- ASQ certification (CQE, CQA) a plus
- Ability to travel up to 10-15% (site visits, sterilization vendor audits)
