Job Description Summary

The Senior 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: 

• Manage the intake of issues through the CAPA Program

• Supports the CAPA initiator with technical writing of the Problem Statement, Containment Plan, and CAPA Determination decisions.

• Supports risk management team to perform risk assessments for product related CAPAs in a timely manner.

• Works with cross-functional leaders to identify appropriate CAPA Owner in a timely manner.

• Initiates CAPA records in TrackWise once all required fields are gathered.

• Works with CAPA Owner to develop an Investigation Plan and Targeted Duration Request for the Investigation phase, as needed.

• Ensures all CAPA records are approved within the required 14-day timeframe.

• Supports CAPAs in Investigation phase and Planning phase as needed.

Qualifications: 

• Bachelor’s degree in Engineering or Science

• Experience in medical device industry required

• Minimum 5 years experience in technical Quality Engineering capacity

• 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, citizen