Senior Stability Engineer - Simpang Ampat, Malaysia - Haemonetics

    Haemonetics
    Haemonetics Simpang Ampat, Malaysia

    2 weeks ago

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    Full time
    Description

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

    Job Details

    Responsibilities:

  • Develops stability and shelf-life strategies for disposable blood processing devices, implementing a tiered risk-based approach to establish and maintain regulatory compliance in support of new product development and sustaining engineering stability studies.
  • Plans and manages stability testing and/or rationales based on changes in manufacturing, supplier information, material, and sterilization changes to medical devices.
  • Ensure that testing meets all internal, international, & domestic test requirements according to ISO, FDA, EU MDR, and GLP.
  • Conduct review of technical requirements and specifications of products in conjunction with product development teams to develop, plan and execute stability and shelf-life studies.
  • , ISO 1135-4, ISO , ISO 9626, ISO 23908 and European Pharmacopoeia.
  • Interact closely with and provide consultative direction to Quality, R&D, Clinical, and Regulatory Affairs within Haemonetics.
  • Support on-site and off-site Regulatory Authority audits for products that may be sold in worldwide markets.
  • Confirms atypical and/or out of specification (OOS) results and participate in product investigation by applying root cause analysis and implementing effective CAPAs.
  • Ensure that stability aspects of new products and product optimizations are assessed, reviewed and maintained throughout all development phases.

    • Job Requirement

  • 5+ years of experience with a Bachelor's degree.
  • Experience in years as specified above in stability/shelf-life studies development, planning, execution and documentation.
  • Bachelor's degree in Engineering, Chemistry, Polymer Science/ Materials Engineering or equivalent.
  • Preferred: Experience with in-vitro diagnostic devices and/or reagents.
  • Preferred: Experience with the following standards: ISO 3826-1, ISO 3826-4, ISO 80369
  • Functional expert in the principles of stability and shelf-life testing of disposable medical devices.
  • Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of stability and shelf-life standards for blood disposable products.

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