BD (Tissuemed Ltd)
Lab Service Quality Engineer
BD (Tissuemed Ltd), Branchburg Township, New Jersey, United States
Lab Service Quality Engineer
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BD (Tissuemed Ltd) Job Description Summary: The Lab Services Quality Engineer is responsible for ensuring quality by design, ensuring that method development and execution is always conducted in compliance with laboratory quality and compliance standards. Supports technical data review and ensures data and documentation generated meet cGMP requirements. Closely collaborates with Technology Development and Operations functions and acts as the technical lead within QA to work with engineering on review of engineering drawings, data analysis, reporting and investigations. Ensures the maintenance and enhancement of the company’s Quality Management System (QMS), with a focus on continuous improvement and operational excellence. We are the makers of possible. BD is one of the largest global medical technology companies in the world. BD’s purpose is Advancing the world of health, from design and engineering to manufacturing and marketing of MedTech products. We foster an environment that supports learning, growth and becoming your best self. Become a maker of possible with us. Key Responsibilities
Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and ISO 13485 Develop and review test protocols, methods, and reports to ensure compliance with design control and risk management requirements Collaborate with cross-functional teams including technology development, operations and business development to support flawless project execution and delivery management Ensure laboratory compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Support root cause investigations, CAPA, OOS/OOT and non-conformance resolution related to design verification testing Provide technical guidance and mentorship to junior engineers and laboratory staff Participate in internal and external audits, including regulatory inspections Maintain and improve quality systems, including CAPA, Nonconformances, calibration and maintenance and equipment qualification Stay current with evolving regulatory expectations for combination products and contribute to continuous improvement initiatives Data Review & Project Release
Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client Execution And Maintenance Of QMS Activities Including
Provide problem solving and root cause analysis expertise to lead / support OOS/Deviation/CAPA investigations Review Test Method Validation and provide quality expertise in the development of test methods and protocols Act as technical QA representative during audits Identify and drive implementation of improvements in current quality systems and processes Achieves KPI objectives by helping develop production/quality data collection processes, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting trending analyses to enable continuous improvement plans Prepare and present quality reports and metrics to senior management Support QMS integration (e.g., ZebraSci) into BD Quality Global procedures and systems Train and guide staff in quality procedures and compliance Education And Experience
Bachelor’s or master’s degree in engineering, Biomedical Sciences, or related field Minimum 5 years of experience in quality engineering, preferably in a combination product or medical device environment Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles Experience with mechanical and analytical testing of drug-device combination products Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485 Excellent analytical, organizational, and communication skills Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA) Experience with Laboratory Information Management Systems (LIMS) is a plus Experience with audits is a plus Qualifications And Skills
Technical writing knowledge and the ability to author Quality System documentation and reports with data analysis Attention to detail and accuracy Problem solving skills Excellent organizational skills to manage multiple priorities in a fast-paced environment Excellent communication skills with the ability to interact at all levels of the organization and with customers/regulators (Note: This description preserves the essential job responsibilities, qualifications and EEO-related content while removing extraneous boilerplate and formatting. )
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at
BD (Tissuemed Ltd) Job Description Summary: The Lab Services Quality Engineer is responsible for ensuring quality by design, ensuring that method development and execution is always conducted in compliance with laboratory quality and compliance standards. Supports technical data review and ensures data and documentation generated meet cGMP requirements. Closely collaborates with Technology Development and Operations functions and acts as the technical lead within QA to work with engineering on review of engineering drawings, data analysis, reporting and investigations. Ensures the maintenance and enhancement of the company’s Quality Management System (QMS), with a focus on continuous improvement and operational excellence. We are the makers of possible. BD is one of the largest global medical technology companies in the world. BD’s purpose is Advancing the world of health, from design and engineering to manufacturing and marketing of MedTech products. We foster an environment that supports learning, growth and becoming your best self. Become a maker of possible with us. Key Responsibilities
Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and ISO 13485 Develop and review test protocols, methods, and reports to ensure compliance with design control and risk management requirements Collaborate with cross-functional teams including technology development, operations and business development to support flawless project execution and delivery management Ensure laboratory compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Support root cause investigations, CAPA, OOS/OOT and non-conformance resolution related to design verification testing Provide technical guidance and mentorship to junior engineers and laboratory staff Participate in internal and external audits, including regulatory inspections Maintain and improve quality systems, including CAPA, Nonconformances, calibration and maintenance and equipment qualification Stay current with evolving regulatory expectations for combination products and contribute to continuous improvement initiatives Data Review & Project Release
Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client Execution And Maintenance Of QMS Activities Including
Provide problem solving and root cause analysis expertise to lead / support OOS/Deviation/CAPA investigations Review Test Method Validation and provide quality expertise in the development of test methods and protocols Act as technical QA representative during audits Identify and drive implementation of improvements in current quality systems and processes Achieves KPI objectives by helping develop production/quality data collection processes, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting trending analyses to enable continuous improvement plans Prepare and present quality reports and metrics to senior management Support QMS integration (e.g., ZebraSci) into BD Quality Global procedures and systems Train and guide staff in quality procedures and compliance Education And Experience
Bachelor’s or master’s degree in engineering, Biomedical Sciences, or related field Minimum 5 years of experience in quality engineering, preferably in a combination product or medical device environment Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles Experience with mechanical and analytical testing of drug-device combination products Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485 Excellent analytical, organizational, and communication skills Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA) Experience with Laboratory Information Management Systems (LIMS) is a plus Experience with audits is a plus Qualifications And Skills
Technical writing knowledge and the ability to author Quality System documentation and reports with data analysis Attention to detail and accuracy Problem solving skills Excellent organizational skills to manage multiple priorities in a fast-paced environment Excellent communication skills with the ability to interact at all levels of the organization and with customers/regulators (Note: This description preserves the essential job responsibilities, qualifications and EEO-related content while removing extraneous boilerplate and formatting. )
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