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.

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

Skills

• Knowledge of ISO 14971 standard for Medical Device Risk Management

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

• Knowledge of regulatory requirements

• 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

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or equivalent field required and 5 years experience

• Master's Degree in Engineering, Life Sciences, or equivalent field required and 2 years experience

• Experience in manufacturing

Preferred Qualifications:

• Experience conducting investigations into product defects/customer complaints
• Experience in medical device industry

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