Staff Quality Engineer

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

Job summary

Becton, Dickinson and Company in San Diego, CA is seeking a Quality Engineer to support new product development and ongoing maintenance of medical devices. You will apply quality engineering skills across design controls, risk management, and regulatory compliance to ensure products meet all standards.

You will collaborate with engineering, manufacturing, purchasing, regulatory affairs, and technical service to investigate CAPAs, conduct root cause analyses, develop test methods, and prepare

Qualifications

• Requires Master’s degree in Engineering or related field with 2 years of work experience in quality engineering for medical devices.
• Experience with design controls, ISO 13485 and risk management (ISO 14971).
• Familiar with FMEA, CAPA, data analysis and verification/validation concepts.

Responsibilities

• Review non-conformances from suppliers and manufacturing; assess impact on product quality.
• Develop test methods and sampling plans; design experiments and analyze data.
• Participate in FDA inspections; coordinate Notified Body audits; conduct internal audits.
• Support product launches and transitions from development to manufacturing.
• Lead root cause investigations; initiate corrective actions and verify effectiveness.

Skills

Statistical analysis

FMEA

Root Cause Analysis

ISO 13485

Quality tools

21 CFR Part 820.30 knowledge

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 5 years experience

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

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

Must reference Job Title & Job Code: R-557022. #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.

Primary Work Location USA CA - San Diego Bldg A&B Additional Locations 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

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.