- Company Name
- Advanced Medical Solutions
- Job Title
- Sterility Assurance Associate
- Job Description
-
**Job Title**
Sterility Assurance Associate
**Role Summary**
Provides technical expertise and leadership on sterility assurance for a global medical device portfolio. Acts as Subject Matter Expert (SME) across design‑to‑production life cycle, ensuring compliance with ISO 11135/11137, ISO 17665, cGMP, MDSAP, and MDR. Interfaces with cross‑functional teams (R&D, QC, packaging, QA) to develop, validate, and maintain sterilization processes, documents, and quality system procedures.
**Expectations**
- Deliver regulatory compliance and technical support for all sterilization activities.
- Maintain up‑to‑date knowledge of national and international standards and industry best practices.
- Lead problem‑resolution initiatives and continuous improvement actions.
- Manage sterilization‑related projects, change controls, and stakeholder communication.
**Key Responsibilities**
1. Technical SME for sterilization: advise on method suitability, validation, and ongoing performance.
2. Ensure compliance with ISO 11135, ISO 11137, ISO 17665, cGMP, MDSAP, MDR across the portfolio.
3. Participate in product design reviews to embed sterility requirements early.
4. Conduct gap analyses, update QMS procedures, and translate standards into site‑level actions.
5. Create and review quality plans, verification/validation protocols, risk assessments, and other sterility‑related documentation.
6. Support audit and inspection activities: CAPA, SCAR, MRB, and non‑conformance investigations.
7. Coordinate and conduct sterilization change‑control projects, including technical assessments and implementation.
8. Provide technical support to commercial and R&D teams on validated sterilization, packaging, and cleanroom operations.
**Required Skills**
- Deep understanding of sterilization science, methods (ethylene oxide, radiation, gas plasma, etc.) and validation.
- Strong knowledge of ISO 11135/11137, ISO 17665, cGMP, MDSAP, MDR, and related regulatory frameworks.
- Experience with QMS tools: CAPA, SCAR, MRB, non‑conformance management.
- Excellent written and verbal communication; ability to translate technical content for varied audiences.
- Project management skills: planning, execution, cross‑functional collaboration.
- Analytical and problem‑solving ability; root‑cause analysis.
**Required Education & Certifications**
- Bachelor’s degree in Life Sciences, Chemistry, Biomedical Engineering, or related field.
- Master’s degree or equivalent experience preferred.
- Certifications or training in ISO 11135/11137, sterility validation, and cGMP regulatory compliance are highly desirable.
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