BD
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. The individual supports technical data review and ensures data and documentation generated meet cGMP requirements. The Lab Services Quality Engineer collaborates with Technology Development and Operations and acts as the technical lead within QA to review engineering drawings, data analysis, reporting and investigations. The role focuses on maintenance and enhancement of the company’s Quality Management System (QMS), with an emphasis on continuous improvement and operational excellence.
Key Responsibilities
Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR parts 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 protocol, laboratory data, audit trails, and reports prior to release to the client Quality Management System
Execute and maintain QMS activities including problem solving and root cause analysis 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 Compliance & Continuous Improvement
Identify and drive implementation of improvements in current quality systems and processes Achieve KPI objectives by helping develop production/quality data collection processes, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting trending analyses for continuous improvement plans Prepare and present quality reports and metrics to senior management Support QMS integration into 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) a plus Experience managing or participating in audits a plus Qualifications and Skills
Technical writing knowledge and skill. Ability to author Quality System documentation, reports including review of data and data analysis Attention to details and accuracy Problem solving skills Excellent organizational ability to manage multiple priorities in a fast-paced, growing business environment Excellent communication skills and the ability to communicate internally at all levels and with customers/regulators At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under "Our Commitment to You". BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information $84,300.00 - $138,900.00 USD Annual
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Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR parts 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 protocol, laboratory data, audit trails, and reports prior to release to the client Quality Management System
Execute and maintain QMS activities including problem solving and root cause analysis 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 Compliance & Continuous Improvement
Identify and drive implementation of improvements in current quality systems and processes Achieve KPI objectives by helping develop production/quality data collection processes, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting trending analyses for continuous improvement plans Prepare and present quality reports and metrics to senior management Support QMS integration into 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) a plus Experience managing or participating in audits a plus Qualifications and Skills
Technical writing knowledge and skill. Ability to author Quality System documentation, reports including review of data and data analysis Attention to details and accuracy Problem solving skills Excellent organizational ability to manage multiple priorities in a fast-paced, growing business environment Excellent communication skills and the ability to communicate internally at all levels and with customers/regulators At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under "Our Commitment to You". BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information $84,300.00 - $138,900.00 USD Annual
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