BD is looking to solve the problem of ensuring compliance with quality standards and regulations in the development and maintenance of medical devices.
Requirements
- 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
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
Other
- 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
- Excellent verbal and written communication skills
- Minimum of 4 days of in-office presence per week
