Supplier QA Engineer

Job Description Summary

For more than 125 years, we have pursued our purpose by driving the world of health™. We are relentlessly committed to a promising future through the development of innovative technologies, services, and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD-from manufacturing to marketing our products-to see the impossible and find transformative solutions that turn our dreams into possibilities-for people today, tomorrow, and in the future.

By aligning and streamlining our work, our Integrated Diagnostic Solutions (IDS) business unit aims to drive growth and innovation in everything from integrated sample management to diagnostic solutions. The Integrated Diagnostic Solutions (IDS) unit is currently seeking:

Supplier Quality Engineer is responsible for providing leadership and guidance to the supplier to ensure compliance to established corporate standards and to regulated agencies for industry (ISO, FDA and others as applicable).
Follow-up supplier quality failure modes reported by incoming inspection and / or production area.
Responsible for the planning, development and implementation of quality systems that support the organization in the successful management of suppliers.

Job Description

Supplier QA Engineer

Job Description Summary:

Responsible for providing leadership and guidance to the supplier to ensure compliance to established corporate standards and to regulated agencies for industry (ISO, FDA and others as applicable). Responsible for the planning, development and implementation of quality systems that support the organization in the successful management of suppliers.

Key Responsibilities:

• Review and maintenance of all Quality Agreements
• Maintain communication with Regulatory to assure accurate identification of critical and crucial suppliers.
• Coordinate the completion of Supplier Surveys/Assessments.
• Work with Procurement/Sourcing during supplier selection to provide quality-related input for potential suppliers.
• Support supplier audits and improvement projects.
• Provide support / actively participate in internal and external audits (FDA, ISO, Corporate, and Internal)
• Work with Corporate project teams to coordinate and implement supplier quality initiatives in the plant.
• Provide guidance on documentation associated with supplier qualification and supplier-driven changes including supplier validations, supplier quality agreements, process controls, and compliance to regulations and industry standards.
• Periodically assess suppliers and Supplier Quality team practices to ensure global regulatory requirements are met.

• Bachelor's degree in engineering or equivalent.
• 2 years of experience, medical device preferred.
• Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification
• Strong working knowledge of statistical quality tools and statistical process control (SPC)
• Strong working knowledge of QSR, ISO, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred.
• Demonstrate effective communication, presentation and influencing skills, bilingual English and Spanish.
  
  BD values equity in the workplace, without discrimination against any disability, social class, ethnicity, age, religion, gender identity, or sexual orientation.