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 Quality Specialist 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 Responsibilities:
1. Consistent application of technical principles, theories, concepts, and quality sciences/ tools.
2. Proven problem-solving skills.
3. Makes measurable improvements to BD processes and procedures.
4. Ensure that all design control and production / process control projects meet applicable regulatory (Local and International), Corporate and Unit requirements.
5. Is a team member representing Quality or new product development and sustaining engineering projects.
6. Review and has Quality Assurance and Engineering approval authority for new and modified design/ process specifications including product performance specifications, test methods, etc.
7. Assist with suppliers and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices.
8. Responsible for technical oversight that include investigations, validations, and Product Assessment.
9. Contributes to the completion of specific programs and projects.
10. Ensure quality conduct of projects, including design, data summary and interpretation and report generation for self and lower-level project developers.
11. Prepares/Revises policies/procedures.
12. Responsible to perform product complaint investigations.
Minimum Requirement:
Bachelor’s degree in engineering or related field.
Min 2 years of experience as a quality specialist in regulated industry. (Med device or pharma strongly preferred).
In depth knowledge of validation processes (TMV, IQ, OQ, PQ)Test Method Validation (TMV), IQ (Installation Qualification), OQ (Operation Qualification) & PQ (Performance Qualification), product complaint investigations, root cause analysis, non conformances.
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.
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