Staff Quality Engineer

Regulatory Jobs; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD (Becton, Dickinson and Company) seeks a quality engineer in San Diego to support development and maintenance of medical devices through rigorous quality engineering practices. You will work with design control, risk management, and cross‑functional teams to ensure compliance with regulatory requirements and product quality.

The role involves root cause analysis, CAPA investigations, and collaboration with manufacturing, regulatory affairs, and suppliers.

Qualifications

• Master’s degree in Engineering (any) or related field and 2 years of experience or a Bachelor’s degree with 5 years of experience.
• Experience with FDA/ISO design controls, risk management, and quality tools.
• Proficiency in technical data analysis and verification/validation approaches.

Responsibilities

• Support new product development and maintenance through quality engineering for medical devices.
• Participate in design control meetings and provide feedback on product quality.
• Coordinate investigations, CAPAs, and corrective actions with cross‑functional teams.
• Prepare reports and assist FDA inspections and internal audits.

Skills

Statistical analysis

Quality tools

Design controls

FMEA

SPC

Root Cause Analysis

CAPA investigations

Education

Master’s degree in Engineering (any) or related field

Bachelor’s degree in Engineering (any) or related field

Tools

TeamCenter

Polarion

AzureDevOps

Job description

We are the people who give possibilities purpose

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.

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 Description Summary:

Support new product development and product maintenance through the application of Quality engineering skills for medical devices. Support projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Participate in design control meetings and provides feedback regarding product quality. Works closely with engineering, manufacturing, purchasing, marketing, technical service, and regulatory affairs on quality issues. Review non-conformances identified by suppliers and manufacturing facilities; assess impact on product quality; and communicate findings and recommendations to appropriate personnel. Develop test methods and sampling plans. Design experiments; collect data; analyze results; prepare reports; present findings and make recommendations based on analysis of data. Write and interpret technical documents such as drawings, specifications, operating procedures, and Form 483 observations. Participate in FDA (Food and Drug Administration) inspections; coordinate Notified Body audits; and conducts internal audits as directed. Support product launches by working with production, quality assurance, regulatory affairs, technical service, and shipping/receiving to ensure successful transition from development to full scale manufacturing. Conduct root cause investigations of product complaints and quality issues; initiate corrective actions; monitor implementation and effectiveness of corrective actions.

Qualifications

Master’s degree in Engineering (any) or related field of study and two (2) years of work experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Engineering (any) or related field of study and two (2) years of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor’s degree in Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Must also have demonstrated experience in the following: Statistical analysis and quality tools; Medical device design controls (21 CFR Part 820.30), ISO 13485, and risk management (ISO 14971); Quality tools and methodologies such as: FMEA, SPC and Root Cause Analysis; Software tools: TeamCenter, Polarion, AzureDevOps or PLM systems; Assessing design changes for impact on product requirements and specifications; Linking product level changes to requirements and specifications, and providing an engineering assessment on whether these changes require re-verification or validation; Analyzing technical data to use in place of functional testing as a form of verification using statistical techniques, electrical engineering, mechanical engineering, and material science to offset testing with analysis; and Investigation techniques to support CAPAs, as well as the software tool in which to document these investigations (trackwise).

Salary offered for the position is: $151,410.00 - $207,400.00/year.

Primary Work Location:

3750 Torrey View Ct, San Diego, CA 92130

Additional Locations:

N/A

Work Shift:

Not Specified

#DNPBD

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 COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company 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.

Primary Work Location

USA CA - San Diego Bldg A&B

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00