Exactech, Inc.
Senior Biocompatibility Scientist, QA
Exactech, Inc., Gainesville, Florida, us, 32635
Senior Biocompatibility Scientist, QA
Department:
QualityEmployment Type:
Full TimeLocation:
Gainesville, FLReporting To:
Mgr. QA, Design Quality Engineering
Description
The Senior Biocompatibility Scientist, QA will develop biocompatibility evaluation strategies, oversee biocompatibility projects, and provide objective evidence to support the biocompatibility of medical devices and materials according to the ISO 10993 series of standards. The Senior Biocompatibility Scientist, QA leverages expertise in the medical device biocompatibility discipline to support the product lifecycle, ensure compliance with regulations, and provide input with respect to biocompatibility of materials and processes for new products, line extensions, and product revisions to currently marketed products.
Key Responsibilities
Implement practical, cost-effective end to end, state-of-the-art approaches to biological evaluation within an evolving regulatory environment.Engage in development and improvement efforts of internal/external procedures and processes supporting the biocompatibility program.Collaborate effectively with cross functional team members in Regulatory, Clinical Affairs, Quality Assurance, Research and Development and Manufacturing Engineering ensuring timeliness of new product development and internally manufactured/externally supplied product biological assessments.Assist with scheduling, planning, and directing biocompatibility project activities, applying the appropriate resources ensuring efficient and effective implementation of New Product Development and Sustaining Engineering, including insourcing and supplier change project initiatives.Develop technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.Manage the biological assessments of multiple projects at one time, providing critical review and interpretation of available data, elevating project constraints to upper management as necessary.Facilitate laboratory testing activities, including, but not limited to, chemical characterization studies, toxicological risk assessments, biological testing, and laboratory investigations.Review, interpret, and summarize testing data ensuring appropriate testing documentation, coordination, and complete internal/external documentation including, but not limited to, biological evaluation plans and biological evaluation reports, leveraging available materials as necessary.Mentor and educate those within the organization that require additional knowledge to assist with biological evaluations (e.g., Supplier Quality, Quality Assurance).Assist in biological safety initiatives for Change Management, CAPAs, HHEs, complaints/field actions providing biological safety expertise when required.Corporate Subject Matter Expert (SME), supporting regulatory submissions, interactions with competent authorities (e.g., US Food and Drug Administration, BSI) and on-site assessments of biological safety compliance.Assist lead auditor for assessment of contract laboratory quality management systems and ISO 17025 compliance to determine overall ISO 10993 analytical capabilities, supporting inclusion in the organization’s supplier quality management system.Know and apply the Quality System and any appropriate Federal and International standards that are applicable to a medical device manufacturing industry and biological safety.
Skills Knowledge and Expertise
Education:Bachelor’s Degree in a related field from an accredited institution required;Degree in Toxicology, Chemistry or Biology or related field of study preferred.Experience:Laboratory and applied research experience required.5-7 years of progressive medical device experience, preferably in orthopedics.2-3 years’ experience performing biological assessments.Knowledge of conduct and interpretation of in vivo and in vitro studies.Experience in instrumentation analysis techniques is a plus (e.g., FTIR, HPLC, GC, IC, ICP-MS, GC-MS).Ability to work collaboratively as a team member across various functions and subject areas in a challenging and changing environment.In-depth working knowledge of ISO 10993 biocompatibility series preferred.In-depth working knowledge of regulatory requirements, including but not limited to FDA and EU MDD/MDR.Extensive experience working in a Design Control environment.Functional/Technical Knowledge, Skills and Abilities Required:Excellent technical writing skills.Excellent organization and project management skills.Strong problem-solving capabilities.Ability to work with all organizational functions and levels.Competency in assessing qualitative and quantitative data required.
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Department:
QualityEmployment Type:
Full TimeLocation:
Gainesville, FLReporting To:
Mgr. QA, Design Quality Engineering
Description
The Senior Biocompatibility Scientist, QA will develop biocompatibility evaluation strategies, oversee biocompatibility projects, and provide objective evidence to support the biocompatibility of medical devices and materials according to the ISO 10993 series of standards. The Senior Biocompatibility Scientist, QA leverages expertise in the medical device biocompatibility discipline to support the product lifecycle, ensure compliance with regulations, and provide input with respect to biocompatibility of materials and processes for new products, line extensions, and product revisions to currently marketed products.
Key Responsibilities
Implement practical, cost-effective end to end, state-of-the-art approaches to biological evaluation within an evolving regulatory environment.Engage in development and improvement efforts of internal/external procedures and processes supporting the biocompatibility program.Collaborate effectively with cross functional team members in Regulatory, Clinical Affairs, Quality Assurance, Research and Development and Manufacturing Engineering ensuring timeliness of new product development and internally manufactured/externally supplied product biological assessments.Assist with scheduling, planning, and directing biocompatibility project activities, applying the appropriate resources ensuring efficient and effective implementation of New Product Development and Sustaining Engineering, including insourcing and supplier change project initiatives.Develop technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.Manage the biological assessments of multiple projects at one time, providing critical review and interpretation of available data, elevating project constraints to upper management as necessary.Facilitate laboratory testing activities, including, but not limited to, chemical characterization studies, toxicological risk assessments, biological testing, and laboratory investigations.Review, interpret, and summarize testing data ensuring appropriate testing documentation, coordination, and complete internal/external documentation including, but not limited to, biological evaluation plans and biological evaluation reports, leveraging available materials as necessary.Mentor and educate those within the organization that require additional knowledge to assist with biological evaluations (e.g., Supplier Quality, Quality Assurance).Assist in biological safety initiatives for Change Management, CAPAs, HHEs, complaints/field actions providing biological safety expertise when required.Corporate Subject Matter Expert (SME), supporting regulatory submissions, interactions with competent authorities (e.g., US Food and Drug Administration, BSI) and on-site assessments of biological safety compliance.Assist lead auditor for assessment of contract laboratory quality management systems and ISO 17025 compliance to determine overall ISO 10993 analytical capabilities, supporting inclusion in the organization’s supplier quality management system.Know and apply the Quality System and any appropriate Federal and International standards that are applicable to a medical device manufacturing industry and biological safety.
Skills Knowledge and Expertise
Education:Bachelor’s Degree in a related field from an accredited institution required;Degree in Toxicology, Chemistry or Biology or related field of study preferred.Experience:Laboratory and applied research experience required.5-7 years of progressive medical device experience, preferably in orthopedics.2-3 years’ experience performing biological assessments.Knowledge of conduct and interpretation of in vivo and in vitro studies.Experience in instrumentation analysis techniques is a plus (e.g., FTIR, HPLC, GC, IC, ICP-MS, GC-MS).Ability to work collaboratively as a team member across various functions and subject areas in a challenging and changing environment.In-depth working knowledge of ISO 10993 biocompatibility series preferred.In-depth working knowledge of regulatory requirements, including but not limited to FDA and EU MDD/MDR.Extensive experience working in a Design Control environment.Functional/Technical Knowledge, Skills and Abilities Required:Excellent technical writing skills.Excellent organization and project management skills.Strong problem-solving capabilities.Ability to work with all organizational functions and levels.Competency in assessing qualitative and quantitative data required.
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