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Lead Biocompatibility Scientist, Quality Assurance

2 months ago

Gainesville, Florida, United States Exactech Full time
Job Overview

The Lead Biocompatibility Scientist in Quality Assurance will be responsible for formulating biocompatibility assessment strategies, managing biocompatibility initiatives, and delivering objective evidence to validate the biocompatibility of medical devices and materials in accordance with the ISO 10993 standards.

This role requires leveraging expertise in the biocompatibility of medical devices to support the product lifecycle, ensuring adherence to regulatory requirements, and providing insights regarding the biocompatibility of materials and processes for new products, product line extensions, and revisions of existing products.

Key Responsibilities
  • Develop and implement innovative, cost-effective biological evaluation methodologies within a dynamic regulatory landscape.
  • Participate in the enhancement of internal and external procedures that underpin the biocompatibility program.
  • Collaborate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Quality Assurance, Research and Development, and Manufacturing Engineering to ensure timely product development and biological assessments.
  • Oversee the scheduling, planning, and execution of biocompatibility project activities, applying necessary resources for effective New Product Development and Sustaining Engineering initiatives.
  • Formulate technical solutions to complex challenges, ensuring alignment with organizational goals.
  • Manage multiple biological assessments concurrently, providing critical analysis and interpretation of data, and escalating project constraints to senior management as needed.
  • Facilitate laboratory testing activities, encompassing chemical characterization studies, toxicological risk assessments, biological testing, and laboratory investigations.
  • Review and summarize testing data, ensuring thorough documentation and coordination of internal and external records, including biological evaluation plans and reports.
  • Provide mentorship and training to team members requiring additional knowledge in biological evaluations.
  • Support biological safety initiatives related to Change Management, CAPAs, HHEs, and complaints, offering expertise in biological safety as necessary.
  • Act as a Corporate Subject Matter Expert (SME) for regulatory submissions and interactions with regulatory authorities.
  • Assist in auditing contract laboratory quality management systems and ISO 17025 compliance to evaluate ISO 10993 analytical capabilities.
  • Apply knowledge of Quality Systems and relevant Federal and International standards applicable to the medical device manufacturing industry.
QualificationsEducation:
  • Bachelor's Degree in a relevant field from an accredited institution is required.
  • Preferred qualifications include a degree in Toxicology, Chemistry, or Biology.
Experience:
  • Required laboratory and applied research experience.
  • 5-7 years of progressive experience in the medical device sector, ideally within orthopedics.
  • 2-3 years of experience conducting biological assessments.
  • Familiarity with in vivo and in vitro study conduct and interpretation.
  • Experience with analytical instrumentation techniques is advantageous (e.g., FTIR, HPLC, GC, IC, ICP-MS, GC-MS).
  • Ability to collaborate effectively across various functions in a dynamic environment.
  • In-depth knowledge of the ISO 10993 biocompatibility series is preferred.
  • Comprehensive understanding of regulatory requirements, including FDA and EU MDD/MDR.
  • Extensive experience in a Design Control environment.
Skills and Abilities:
  • Exceptional technical writing capabilities.
  • Strong organizational and project management skills.
  • Robust problem-solving abilities.
  • Capability to engage with all organizational levels and functions.
  • Proficiency in evaluating qualitative and quantitative data.