BD Nogales Norte · 2 days ago
Design Quality Engineer II
San Diego, CA
Full-time
Onsite
Mid Level
$81K/yr - $133K/yr
3+ years expBD is one of the largest global medical technology companies in the world, seeking a Design Quality Engineer II to support product design changes and maintenance for medical devices. This role involves ensuring products meet quality standards and regulatory requirements throughout the product lifecycle.
Consumer Goods
Responsibilities
Develop, implement, and maintain quality plans, procedures, and specifications in accordance with internal standards and regulatory requirements (e.g., FDA, ISO 13485)
Participate in design control activities, including design reviews, risk management (DFMEA, PFMEA), and verification/validation planning and execution
Conduct root cause analysis for product non-conformances, customer complaints, and deviations, and implement effective corrective and preventive actions (CAPA)
Lead or support internal and external audits (e.g., supplier audits, regulatory inspections) to ensure compliance with quality system requirements
Analyze quality data (e.g., trend analysis, defect rates, yield) to identify areas for improvement and drive continuous improvement initiatives
Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to resolve quality issues and promote a culture of quality
Perform statistical analysis to evaluate process capability, product reliability, and validate test methods
Review and approve manufacturing documentation, engineering changes, and process validations
Train and mentor junior quality personnel on quality system requirements and best practices
Prepare and present quality reports and metrics to management
Qualification
Required
Bachelor's degree in engineering (e.g., Biomedical, Mechanical, Electrical, Industrial)
Minimum 3 years of experience in a design quality engineering role within medical device industry
Strong understanding of quality system regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485)
Proven experience with root cause analysis methodologies (e.g., 8D, 5 Whys, Fishbone diagrams) and CAPA systems
Proficiency in statistical analysis tools and techniques (e.g., Minitab, SPC, Gage R&R)
Demonstrated experience in design control, risk management, and verification/validation activities
Excellent written and verbal communication skills with the ability to effectively interact with all levels of the organization
Ability to work independently and as part of a cross-functional team in a fast-paced environment
Preferred
ASQ certifications (e.g., CQE, CSSBB) are a plus
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
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