Job Description Summary

The Staff Quality Engineer supports the Operations and Quality teams to ensure that sustaining projects meet their Quality objectives while striving for on-time delivery and cost management. This position is a key member of sustaining project teams and is responsible for product & process development to ensure effective quality management of released product. The Staff Quality Engineer champions Quality’s interests as it relates to project scope, requirements, design, build, change management, and implementation, and defines and drives the Quality components of the overall project plan. Works with Quality and Operations to ensure resources are available to execute project plans to meet budget and timeline expectations in an efficient and effective manner.

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. 

Duties and Responsibilities  

• Extensive knowledge of quality engineering principles (e.g. acceptance sampling, statistical process control, measurement/test methods, quality planning, failure investigation, design of experiments, process FMEA, value stream mapping, hypothesis testing, descriptive statistics, process capability)

• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

• Provides training for product development teams and continuous improvement teams on best practices.

• Develops complex validation protocols based on business and operations needs, strategies, and requirements.

• Ensure product development and validation programs meet requirements of FDA and ISO when applicable.

• Leads execution of especially complex non-conforming material (Quality Notification) issues, identifies and leads changes to improve the processes consistently result in effective control and efficient operations.

• Track record of root cause determination and effective corrective/preventive action implementation.

• Proficient in all areas of the CAPA process.

• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.

• Conducts/leads Quality System audits. Provides input to Management Review.

• Leads risk management activities including risk management reviews, risk analysis, updating/maintaining process hazard analysis, and presenting to Risk Management board.

• Provides consultation to product teams on strategies to comply with applicable regulatory (local and international), Corporate, and Segment requirements

Required Qualifications:

• Bachelor’s degree in Engineering or STEM related field with 8 years experience in medical device industry

• Minimum 5 years experience in a technical role e.g.  Design, Production Engineering, Quality Engineering in regulated industry

• Minimum 3 years experience with transferring products from design phase to production phase

• Knowledge of statistical analysis and tools e.g., ANOVA, two sample T test

• Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO10993)

• Results orientation with strong written and oral communications skills to lead cross-functional teams.

• Strong problem identification and problem-solving abilities.

Preferred Qualifications:

• Quality Certification preferred (e.g., CQE)

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 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/Affirmative Action 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. 

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 - $199,800.00 USD Annual

Salary : $121,100 - $199,800