Quality Engineer

Responsibilities

• Implement and operate the Quality System for the economic control of raw materials, in-process, and finished products.
• Review inspection criteria, methods, and procedures to ensure acceptable quality standards.
• Investigate product complaints and direct activities required for timely corrective action implementation.
• Provide support for cGMP compliance in product and process validations and transfers.
• Perform and review IQ, OQ, and PQ for manufacturing, packaging, and test equipment.
• Conduct audits to ensure compliance with BD procedures, specifications, and regulatory requirements.
• Monitor quality trends and conduct technical and statistical investigations on quality problems.
• Provide technical and quality support to suppliers, Manufacturing Engineering, and Customer Service.

Requirements

• Bachelor's Degree in Engineering.
• 3+ years of experience in quality control or validation within a medical device manufacturing environment.
• Thorough knowledge of CGMP, ISO 13485, and OSHA.
• Strong statistical analysis skills and the ability to communicate data-driven solutions.
• Bilingual proficiency in English and Spanish (written and oral).
• Proficiency in computer programming and software applications.
• Ability to work onsite in Humacao, Puerto Rico.
• Willingness to travel as required.

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we look at the impossible to find transformative solutions that turn dreams into possibilities.