Job Description Summary

The Staff Quality Engineer will support the implementation of the CAPA system for the Infusion MMS business unit, in accordance with QMS policies and procedures. This role supports the development and maintenance of the CAPA process to ensure corrective actions are timely and effective according to established 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:

• Manages the Implementation of CAPAs and the associated action items.

• Works with the CAPA Owner to identify project planning resources for defined action items and develop a Targeted Duration Request, as needed.

• Initiates action items in TrackWise for planned action items approved in the CAPA.

• Supports Action Owners with action item completion and summaries.

• Supports CAPA Owners with the Implementation Summaries and/or Extension Requests.

• Works with the CAPA Owner to develop and finalize the VOE Plan

• Ensures CAPA phases are approved by the defined due date in TrackWise.

Qualifications:

• Bachelor’s degree in Engineering or Science

• Experience in medical device industry required

• Minimum 8 years experience in technical Quality Engineering space

• Knowledge of FDA regulations and ISO standards

• Excellent communication skills, both written and verbal

• Ability to work independently and collaboratively as part of a team

• Strong analytical and problem-solving abilities

• Proficiency in Microsoft Office Suite

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 CA - San Diego TC Bldg