Quality Engineer

Overview

Quality Engineer role at BD Nogales Norte. This position assists in the establishment, implementation, and maintenance of programs crafted to assure control of processes and products toward established standards of quality. Uses problem solving techniques to increase quality and efficiency within the Business Unit / Department and supports product leadership and risk management of new product development, product launches and sustaining activities.

Job Description

We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose. It takes the imagination and passion of our teams—from design and engineering to manufacturing and marketing of our Med Tech products—to look at the impossible and find transformative solutions.

We value an environment where you are supported to learn, grow and become your best self. Become a maker of possible with us.

• Develop, change, and supervise Quality inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
• Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address process/product issues.
• Documentation of activities along with the review and maintenance of operating procedures as well as department specific-procedures.
• Develop, implement, and improve Quality procedures applicable to the manufacturing process for assigned product lines.
• Coordinate efforts with other Departments to establish controls and process capabilities for assigned product lines.
• Actively support and provide input for process validation, process acceptance, internal and external audits and resulting corrective actions.
• Supervise the performance of assigned product lines regarding product quality, scrap, rejection rates and other applicable metrics.
• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and cost.
• Assume a leadership role in analyzing and resolving process/product issues.
• Develop, or improve test methods for inspection, including Test Method Validation.
• Monitor customer complaints and trends. Responding with specific corrective actions and customer interfacing as needed.
• Ensure that all company safety rules and regulations are followed and promoting general plant safety.
• Develop/update and implement procedures to stay in sync with corporate and industry standards.
• Day-to-day supervision and coordination of QA Technicians.
• Other duties and projects, as assigned.

• Bachelor’s degree in engineering, and minimum of four (4) years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry OR
• Master’s degree in engineering, and minimum of two (2) years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent regulated industry.

• Preferred Qualifications Quality Engineering Certification (ASQ) or equivalent
• Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
• Sophisticated statistical and risk assessment techniques.
• Solid understanding of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
• Ability to make and present risk-based decisions.
• Strong interpersonal skills.
• Ability to analyze and optimize manufacturing and quality systems.
• Ability to build and provide training.
• Problem solving ability.
• Ability to create, review and coordinate test protocols and reports.
• Ability to generate engineering proposals.
• Oral and written presentation skills.
• Ability to Lead multi-functional teams.
• Understanding of regulatory requirements including ISO 13485, ISO 14971.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we…