Job Description Summary

As directed by the Associate Director, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance 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. 

Job Summary:
The Senior Quality Engineer will be responsible for all aspects of the product development process related to ensuring compliance with quality standards and regulations. This includes developing and implementing quality plans, protocols, procedures, and guidelines; performing inspections, tests, and analyses on products at various stages in the production cycle; preparing reports summarizing findings and recommendations; and maintaining documentation related to product development activities. The successful candidate must have strong knowledge of regulatory requirements as well as experience working within a manufacturing environment. They should also possess excellent communication skills to effectively collaborate with cross-functional teams throughout the organization.

Responsibilities

• Develop and implement quality plans, protocols, procedures, and guidelines for new or existing products

• Perform inspections, tests, and analyses on products at various stages in the production cycle

• Prepare reports summarizing findings and recommendations

• Maintain documentation related to product development activities

• Collaborate with cross-functional teams throughout the organization

• Monitor product performance during clinical studies or other evaluations

• Conduct investigations into product defects or customer complaints

• Ensure compliance with relevant laws, regulations, and industry standards

• Stay up-to-date on advances in technology related to medical device manufacturing processes

• Provide guidance on quality issues encountered during product development projects

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or equivalent field required

• Minimum of 5 years of experience in medical device industry preferred

• Knowledge of ISO 14971 standard for Medical Device Risk Management preferred

• Familiarity with Good Manufacturing Practices (GMP) and Design Controls processes desired

• Experience conducting investigations into product defects/customer complaints strongly preferred

• Ability to read drawings and specifications

• Strong understanding of product development lifecycle phases

• Proficiency in Microsoft Office suite including Word, Excel, PowerPoint, and Project

• Excellent verbal and written communication skills

• Ability to work independently as well as part of a team

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. 

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift