BD Nogales Norte
Senior Staff Software Quality Engineer
BD Nogales Norte, Durham, North Carolina, United States, 27703
Senior Staff Software Quality Engineer
BD Nogales Norte – USA NC, Durham – Full‑time, Mid‑Senior level. Responsibilities
Serve as the quality cornerstone for multi‑functional design teams, championing excellence in new product development and sustaining engineering. Orchestrate comprehensive quality strategies throughout the design control lifecycle, from initial planning through verification and validation to risk management and regulatory compliance. Provide expert guidance on quality system implementation, with specialized focus on design controls. Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval. Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets. Ensure robust verification and validation protocols that definitively confirm design specifications and requirements. Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation. Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews. Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently. Lead sophisticated root cause investigations and structured problem‑solving initiatives for both development and manufacturing challenges. Curate impeccable technical files and Design History Files that withstand regulatory scrutiny. Orchestrate continuous improvement initiatives by facilitating multi‑functional collaboration and innovation. Demonstrate mastery of quality engineering principles, methodologies, and industry standards. Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction. Leverage deep knowledge of software quality assurance throughout the development lifecycle. Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies. Serve as a mentor and knowledge resource for developing quality professionals. Qualifications
Bachelor’s degree in engineering or a related field and 15 years’ experience emphasizing R&D development, Quality Engineering and Design Controls. Or Master’s degree in engineering or a related field and 10 years’ experience emphasizing R&D development, Quality Engineering and Design Controls. Ability to travel up to 10%. Why Join Us?
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.
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BD Nogales Norte – USA NC, Durham – Full‑time, Mid‑Senior level. Responsibilities
Serve as the quality cornerstone for multi‑functional design teams, championing excellence in new product development and sustaining engineering. Orchestrate comprehensive quality strategies throughout the design control lifecycle, from initial planning through verification and validation to risk management and regulatory compliance. Provide expert guidance on quality system implementation, with specialized focus on design controls. Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval. Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets. Ensure robust verification and validation protocols that definitively confirm design specifications and requirements. Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation. Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews. Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently. Lead sophisticated root cause investigations and structured problem‑solving initiatives for both development and manufacturing challenges. Curate impeccable technical files and Design History Files that withstand regulatory scrutiny. Orchestrate continuous improvement initiatives by facilitating multi‑functional collaboration and innovation. Demonstrate mastery of quality engineering principles, methodologies, and industry standards. Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction. Leverage deep knowledge of software quality assurance throughout the development lifecycle. Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies. Serve as a mentor and knowledge resource for developing quality professionals. Qualifications
Bachelor’s degree in engineering or a related field and 15 years’ experience emphasizing R&D development, Quality Engineering and Design Controls. Or Master’s degree in engineering or a related field and 10 years’ experience emphasizing R&D development, Quality Engineering and Design Controls. Ability to travel up to 10%. Why Join Us?
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.
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