BD Nogales Norte · 1 day ago
Staff Quality Engineer - Design & Development
Durham, NC
Full-time
Onsite
Lead/Staff
10+ years expBD is one of the largest global medical technology companies in the world. They are seeking an accomplished and driven Software Quality Engineer to lead their core quality team for Pharmacy Automation Central Fill solutions, ensuring compliance engineering standards and safety certification for high-volume pharmacy sites.
Consumer Goods
Responsibilities
Serve as the core team quality lead for design and development projects, including new product introductions and sustaining engineering efforts
Oversee all quality aspects of the design control process: quality planning, verification and validation (V&V), risk management, and regulatory compliance
Lead the preparation and maintenance of technical files, Design History Files (DHFs), and documentation required for regulatory submissions and audits
Collaborate closely with cross-functional teams (R&D, Regulatory, Manufacturing, and Program Management) to ensure design control deliverables meet internal and external standards
Drive root cause analysis and structured problem-solving for nonconformities
Mentor and coach team members, fostering a culture of quality, safety, and continuous improvement
Actively participate in product risk assessments, hazard analyses, and design reviews
Stay current with evolving global safety and compliance standards relevant to central fill pharmacy automation
Qualification
Required
Bachelor's degree in Engineering (or related field)
10 years of experience in quality assurance, with a strong focus on design control and Quality Management Systems
Experience with regulatory and international standards, including EU MDR 2017/745, ISO 9001, ISO 14971, and relevant hardware safety standards
Preferred
Experience with lean or six sigma methodologies applied to hardware quality processes
Prior success in achieving safety certifications for large-scale automation or central fill systems
ASQ Certified Quality Engineer (CQE) or equivalent certification
Experience supporting hardware/software integrated systems and working with central fill or automation technologies
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase