Job Description Summary

The Quality Engineer II is responsible for validation of new processes or process improvement, identifying critical parameters, experimentation to verify optimum setting or configurations, resolving problems with equipment and processes, and the site calibration program.

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. 

The Quality Engineer II is responsible for validation of new processes or process improvement, identifying critical parameters, experimentation to verify optimum setting or configurations, resolving problems with equipment and processes, and the site calibration program.

Main Responsibilities:
1. Ensure compliance with regulatory requirements for both domestic and international markets; participates in U.S. FDA inspections as required.
2. Participate in multi-functional teams responsible for developing and implementing robust quality assurance systems.
3. Apply statistical techniques and other problem solving methods to identify root causes and implement effective corrective actions.
4. Lead investigations related to product complaints, customer notifications, and nonconformances.
5. Develop test methods, specifications, and other technical documents.
6. Maintain quality records and documentation including CAPAs, audit findings, training, and investigation reports.
7. Provide guidance and training to production personnel on quality issues.
8. Review and approve process changes (PCN) prior to implementation ensuring the impact on product quality and safety is understood and controlled.
9. Monitor key performance indicators and metrics reporting results to management.
10. Represent Quality department on new product development projects.

Qualifications:

• Bachelor's degree or equivalent experience education. Master's degree preferred.

• Minimum of 2-3 years relevant work experience: validations in an FDA regulated environment, writing protocols, performing & writing reports.

• Experience in GMP/GDP environment highly desirable.

• Advanced computer skills, including Microsoft Office Suite applications.

• Strong communication and interpersonal skills.

• Ability to effectively communicate technical information verbally and in writing to peers and senior management.

About BD 
Every day, the donation of blood saves lives and improves the health and wellbeing of patients around the world. BD has been a leading provider of safe and affordable medical supplies and devices for donors and patients for more than 60 years. Today, BD provides an extensive selection of prefilled syringes, needles, blood collection tubes, and kits for blood collection, plasma collection, and cellular therapies.  

In addition to its commitment to philanthropy through the BD Foundation, BD also has a long history of investing in its communities and employees. Since 2010, BD has invested more than $2 billion in strategic acquisitions and capital improvements, adding jobs and revenue for many communities across the United States.  

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 GA - Grayson

Additional Locations

Work Shift

NA (United States of America)