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Sterilization Sciences Specialist

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Job Type
Direct Hire
Aug 07, 2017
Job ID
Sterilization Sciences Specialist
Sterilization Sciences Specialist
We are looking for a strong, self-motivated Sterilization Specialist to join and support our growing corporate team.  We are looking for an experienced professional to continue our development and enhancement of efficient, best in class, systems supporting new product development for sterilization and end-user cleaning.  You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to supporting continued business growth and expansion initiatives.  This is an opportunity to use your background and experience to leave a lasting mark on a fast-paced, growth-oriented, organization.  Candidates must be committed to excellence in all areas and take pride in providing elegant and scalable solutions to complex problems supporting company business interests.
About You: 
  • Motivated, driven to learn, and thrive in a dynamic and fast paced environment;
  • Have a track record of continuous improvement of processes and programs to strive for efficiencies while maintaining high quality and compliant outputs;
  • Enjoy a dynamic, team based atmosphere and modern work environment.Some Details:
  • In-Depth understanding of EO, Radiation, and/or Steam sterilization processes;
  • Hands-on experience in validation activities related to systems and products, specifically to the medical device industry;
  • Intimate working knowledge of relevant standards (i.e. ANSI/AAMI/ISO 11135, 11137, ST79, etc.);
  • Full understanding of state of the are / best practice and requirements governing the medical device industry related to sterilization design, validation, maintenance and monitoring programs; 
    Main Objective:
    Maintain company sterilization and end-user reprocessing projects in accordance with Quality Systems Requirements.
    Essential Duties and Responsibilities:
  • Participate in design review meetings and as a key member of product design teams to assess and validate devices for proper sterilization methods, e.g., radiation, ethylene oxide, and end-user reprocessing etc.;
  • Direct and maintain global corporate programs for sterilization cycle maintenance and end-user cleaning and sterilization instructions;
  • Ensure corporate sterilization programs are maintained in accordance with all relevant international standards, e.g., ISO 11135, ISO 11137, ISO 17665, etc. as well as domestic and foreign regulatory requirements;
  • Perform documented assessments, and validations as required of product and process changes for impact to sterilization process efficacy;
  • Act as lead auditor and/or subject matter expert for quality management system audits of global supplier base including critical contract manufacturers, sterilization service providers, and laboratories in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives;
  • Support manufacturing organizations in defining requirements for environmental and viable / non-viable contamination prevention controls;
  • Ensure proper maintenance of files demonstrating internal and vendor compliance and performance including authoring and/or reviewing sterilization validations and product assessments into existing cycles, routine product and environment monitoring reports, non-conformances, CAPA’s, etc..
  • Encourage a continuous process improvements environment
  • Must be able to travel up to 10% of the time. 
    Education and Experience:
    Bachelor’s degree in industrial science, engineering, biology/microbiology, or related science field required.
    3 years’ experience in sterilization, validation, medical device quality assurance, laboratory operations, or related field required
    Knowledge and Skill Requirements/Specialized Courses and/or Training:
    Specialized training manufacturing operations, terminal sterilization methods, industrial statistics, and technical writing preferred.
    Machine, Tools, and/or Equipment Skills:
    Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company).  Experience with Solidworks, Minitab, and corporate ERP systems preferred.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.