Quality Specialist

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.

• Consistent application of technical principles, theories, concepts, and quality sciences/tools.
• Proven problem‑solving skills.
• Make measurable improvements to BD processes and procedures.
• Ensure that all design control and production/process control projects meet applicable regulatory (Local and International), Corporate and Unit requirements.
• Represent Quality or new product development and sustaining engineering projects as a team member.
• Review and has Quality Assurance and Engineering approval authority for new and modified design/process specifications including product performance specifications, test methods, etc.
• Assist with suppliers and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices.
• Responsible for technical oversight that includes investigations, validations, and Product Assessment.
• Contribute to the completion of specific programs and projects.
• Ensure quality conduct of projects, including design, data summary and interpretation and report generation for self and lower‑level project developers.
• Prepare/Revise policies and procedures.
• Perform product complaint investigations.

• Bachelor’s degree in engineering or related field.
• Minimum 2 years of experience as a quality specialist in a regulated industry (medical device or pharma strongly preferred).
• In‑depth knowledge of validation processes (TMV, IQ, OQ, PQ), test method validation, product complaint investigations, root‑cause analysis, non‑conformances.

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://

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.

Primary

Work Location:

USA PR - Anasco