* Job Title: Senior Specialist Sterilization
* Contract: Approx 6 months
* Location: Remote
SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
Position Overview:
* Subject Matter Expert in Medical Device Sterilization and associated international medical device regulations.
* Project focused on evaluation of existing sterilization activities and subsequent remediation plans.
* Focused on Infusion device products, produced in Denmark and Mexico, fulfilling requirements from current relevant sterilization standards such as:
-EN ISO 11135: Sterilization of health care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
-EN ISO 10993-1: Biological Evaluation of Medical Devices - Evaluation and Testing
-EN ISO 10993-7: Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals
* This functional description applies to a designated Sterilization SME, he or she should be aware of the fact that in this capacity he/she has a special obligation to support the work that prevent the occurrence of risks that may cause non-sterile products.
Key Responsibilities:
This role will focus on:
MDR compliance of IC products relating to sterilization activities i.e.:
1. Compliance of existing product validation data and reports
2. Compliance of existing procedures and policies
3. Production of compliance gap assessments
4. Production of remediation plans
5. Assessment of existing sterilization processes at manufacturing and partner facilities
6. Provide support in connection with product registrations and/or inquiries from authorities and customers, and customer audits.
7. Support training of QA/QC staff related to release of sterilized products.
8. Participate in projects to support sterilization, sterility assurance, contamination controls and sterilant residue related projects.
Skills & Experience:
* Excellent communication skills
* Proficiency in MS Office (required)
* Project management experience
Qualifications/Education:
* * BSc in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or min 5 years or more experience if no appropriate science degree.
* Demonstrates expert knowledge of ethylene oxide and radiation principles and industry standards and experience in sterilization process controls is a must.
* Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards.
* Demonstrates experience in dealing with regulatory bodies directly related to medical device sterilization compliance.
* Fluent in English, both verbally and in writing (required)
* Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (required)