BD is looking to ensure new and existing medical devices meet quality standards consistent with both Corporate and Business Unit policies while meeting all design control and other regulatory requirements.
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
- Experience conducting investigations into product defects/customer complaints
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
- Monitor product performance during clinical studies or other evaluations
- Conduct investigations into product defects or customer complaints
- Provide guidance on quality issues encountered during product development projects
Other
- Collaborate with cross-functional teams throughout the organization
- Ensure compliance with relevant laws, regulations, and industry standards
- Stay up-to-date on advances in technology related to medical device manufacturing processes
- Excellent verbal and written communication skills
- Experience in medical device industry
