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Sterilization/Compliance Engineer

Company: SearchRSA
Location: Daytona Beach
Posted on: November 6, 2019

Job Description:

Medical device company focused on disposable medical device contract manufacturing near the Daytona Beach area.
*must be a US citizen or permanent resident*must have a medical device engineering background
JOB TITLE: Regulatory Compliance/Sterilization Engineer(50% Regulatory Compliance and 50% Sterilization Engineering)
SUMMARYResponsible for the hands-on execution associated with projects in Medical Device manufacturing regulatory compliance, work performed by our contract sterilizer, and related microbiological testing, and for company compliance to ISO and FDA standards.

  • BS in Engineering; Chemical, Mechanical, Biomedical or equivalent.
  • 5+ years in medical device sterility assurance, sterilization operations or testing environment.
  • 5+ years in medical device Regulatory Compliance experience.
  • In-depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Radiation sterilization).
  • In-depth understanding of the following standards and regulations ISO 11135, ISO 17665, ISO 11137, ISO 14644, ISO 13485, FDA 21 CFR Part 820
  • Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)DESIRED
    • Strongly desired but not required - Regulatory Affairs Certification (RAC)
    • Previous experience with Class II, Single-Use and Class III medical devices preferred.
      Sterilization Responsibilities
      • Assists new product development efforts by leading the review and approval of sterilization validations and product adoptions. This includes writing protocols and summary reports for both paper and physical adoptions to meet applicable ISO and FDA requirements.
      • Leads and monitors annual evaluation requirements of sterilization processes to ensure compliance to applicable ISO and customer requirements
      • Ensures proper execution of sterilization validations. Works with customer and contract sterilizer to ensure timely and accurate execution of validations.
      • Provides technical support and act as subject matter expert for contract ethylene oxide and gamma sterilization, non-routine testing (Bacterial endotoxin; Bioburden; Biocompatibility; EO residual testing; Shelf life/aging; and Transportation), maintaining flow of development and commercial products.
      • Works with contract sterilizer and customers as necessary to address any anomalies during the sterilization cycle. All anomalies are to be resolved in 48 hours or less of identification.
      • Develops and optimizes sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilization of new products.
      • Oversees and ensures compliance to standards for bioburden and environmental monitoring programs for all products and cleanrooms. 100% compliance to standards.
      • Leads environmental testing and reporting by developing and reviewing protocols, test plans and coordinating with service providers.
      • Develops Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
      • Establishes preventive maintenance program for sterilization, requalification, product loading, and material handling. 100% compliance with Federal, State and local safety/environmental regulations.
      • Leads or participates in auditing contract labs and sterilizers
        Regulatory Responsibilities
        • Provides direction to company personnel to establish policies, procedures and accountability measures that ensure regulatory compliance.
        • Participates in product development through involvement in project team meetings, including risk assessment(s)
        • Reviews and approves test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) to ensure they will meet regulatory requirements
        • Assists in the development, review and approval of product labels, instructions for use, and promotional materials to ensure regulatory requirements are met.
        • Responsible for leading and executing assigned activities associated with regulatory compliance. Keeps abreast of changes to regulations and ensures Quality System complies with any new regulations. Zero (0) major ISO, FDA or customer findings because of an audit.
        • Acts as the Management Representative for all external audits including FDA, ISO and Customers. Hosts representative and ensures requested information is provided so that the audits can be completed quickly and accurately. Makes sure the audit findings are handled properly with the QMS and that any actions are completed properly and in a timely manner. Communicates as necessary before, during and after the audits to ensure favorable outcomes.
        • Coordinates continuous education and training of all company personnel in CGMP's, QSR's and ISO standards/guidelines. Ensures effectiveness of the training.
        • Conducts Management Review process in accordance with ISO standards.
        • Develops internal audit plan, oversee internal audits and assure that 100% of internal audits are completed per plan in both locations.
          WORKING CONDITIONS:Varying from a good working conditions in office environment with regular exposure to manufacturing areas to somewhat undesirable working conditions with exposure to fumes, noise, grease and dirt, with no element continuously present to the extent of being disagreeable. Must be able to travel within and outside the United States.

Keywords: SearchRSA, Daytona Beach , Sterilization/Compliance Engineer, Engineering , Daytona Beach, Florida

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