Job Description Summary Quality Engineer reporting into the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices.
This role will handle projects and tasks, from product development 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.
This position works closely with multi-functional teams within the organization such as Production, Engineering, Research and Development (R&D), Regulatory Affairs and others to provide mentorship on quality matters.
About the role Main responsibilities will include: Ensure compliance with all relevant regulatory requirements including ISO13485.
Moderate level application of technical principles, theories, concepts, techniques and quality sciences/tools.
Implements solutions to routine problems of moderate scope.
Follows company procedures and makes basic procedural updates.
Developing solid understanding of applicable regulatory, Corporate and/or Unit requirements.
Communicates across functions/departments for assigned areas of responsibility.
Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
Provides audit support (preparation, closure, etc.
activities).
About you - Degree or equivalent experience in engineering or related technical field.
- Experience in medical device industry preferred.
- Knowledge of quality management principles, methods and techniques.
- Strong understanding of ISO13485 and other applicable regulations.
- Training in statistics.
Class II / III medical device experience (preferred).
- Knowledge of design control principles (preferred).
- Ability to provide support to internal/external audits.
- English level C1.
- Willingness to learn.
- Great team player.
- Ability to go for business travel.
Click on apply if this sounds like you!
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.
To learn more about BD visit: https://bd.com/careers Primary Work Location ESP San Agustin del Guadalix Additional Locations Work Shift #J-18808-Ljbffr