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Job Description Summary

As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and is accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices. This person will handle 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.

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.

Responsibilities:

+ **Design Control Leadership:** Provide guidance and quality oversight to ensure robust design control programs aligned with regulatory requirements and industry standards

+ **Product Development Support:** Support new product development and existing product sustaining activities, ensuring work follows proper design control and meets BD and FDA regulatory requirements

+ **Documentation Management:** Ensure adequate design control documentation and records are maintained to support the complete lifecycle of design history

+ **Design Control Execution:** Support execution of design control activities including project planning, design inputs, critical-to-quality characteristics, risk analysis, design reviews, validations, verifications, and design history files

+ **Cross-functional Training:** Provide guidance and training to associates across departments to increase knowledge of regulations and standards.

+ **Statistical Analysis:** Evaluate design verification results and data using statistical analysis to ensure designs deliver acceptable quality levels during manufacturing with properly established product specifications

+ **Manufacturing Transfer:** Ensure designs are appropriately specified and established before transferring into manufacturing to mitigate risks

+ **Quality Approval:** Review and authorize quality approval for new product and device design specifications, including performance specifications, test methods, acceptance criteria, and release

+ **Quality Issue Resolution:** Review work performed by R&D and other business units to ensure quality issues are adequately addressed with appropriate corrective actions

+ **Validation Support:** Work with the Validation team to provide Quality Engineering support for product/device transfer, scale-up, and process validation

+ **Risk Management:** Lead or participate in ISO 14971 Risk Management activities appropriate to initiatives or situations

+ **Quality Data Monitoring:** Monitor quality data from various sources (Product Incident Reports, Manufacturing reports, Service reports, customer feedback) to identify, investigate, troubleshoot and resolve quality issues

+ **CAPA Management:** Initiate Corrective and Preventative Action plans and perform efficacy follow-up

+ **Supplier Management:** Conduct supplier evaluations and establish required controls to meet BD and regulatory requirements

+ **Audit Participation:** Participate in supplier capability and internal audits to evaluate effectiveness of GMPs and established Quality Systems

+ **Regulatory Support:** Assist Regulatory Affairs by providing input for submissions or responses to agency queries and support regulatory inspections

+ **Field Action Leadership:** Lead investigations and field activities relating to Field Corrective Actions when needed

• **Qualifications:**

+ Bachelor’s degree in STEM and six (6) years of engineering experience, OR Master’s degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required.

+ Experience in medical device industry is required.

+ American Society of Quality (ASQ) certification (CQE, CQA, etc) preferred.

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 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.

Required Skills

Optional Skills

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Primary Work Location

USA UT - Salt Lake City

Additional Locations

Work Shift

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.