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 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.
Salary Range : 106,600.00 - 175,900.00 USD Annual
Required Skills
Optional Skills
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Primary Work Location
USA NJ - Franklin LakesAdditional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$106,600.00 - $175,900.00 USD AnnualRecommend
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ