Job Description Summary

As Directed by the Quality manager, the Design Quality Engineer II is accountable for supporting product design changes and product maintenance through the application of quality engineering skills for medical devices. this person will play active role in the processes to ensure products meet quality standards consistent with both corporate and business unit policies while meeting all design control and other regulatory requirements.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary
The Quality Engineer II will support the development, implementation, and maintenance of quality systems to ensure products meet established standards and regulatory requirements. This role involves active participation in all phases of the product lifecycle, from design to post-market surveillance, to drive continuous improvement and product excellence.

Job 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.

Job Qualifications

• 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.

• ASQ certifications (e.g., CQE, CSSBB) are a plus.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for C