Quality Engineer

Becton Dickinson; Reynosa; On-site; MXN 240,000 - 360,000; Full time

Job summary

Becton, Dickinson, and Company is seeking a QA Engineer for our Reynosa facility. The role emphasizes root-cause analysis, corrective actions, and robust QA processes to ensure GMP and ISO compliance across manufacturing lines.

Candidate should hold a Bachelor’s in engineering or equivalent with at least 2 years in medical devices. English and Spanish bilingualism is preferred as part of cross-functional collaboration.

Qualifications

• 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 SPC.
• Strong working knowledge of QSR, ISO, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred.
• Bilingual English and Spanish (preferred).

Responsibilities

• Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and technology transfers.
• Lead the product and process transfer; meet the transfer due date with minimal quality issues.
• Develop and maintain quality and manufacturing documentation to comply with standards.
• Support the Quality Engineer Manager and Quality Manager in budget activities.
• Investigate root causes of quality problems using DOE, ANOVA, Regression Analysis, etc.
• Improve inspection, testing, and documentation to meet customer requirements.
• Ensure GMP, ISO, and corporate guidelines are followed.
• Oversee In-Process Inspection on assigned lines.
• Identify opportunities (NC) and implement corrective actions focusing on root cause.
• Evaluate customer complaints and perform Quality Events.
• Design methods to improve inspection and testing for manufacturing and engineering.
• Participate in third party audits (ISO, FDA).
• Perform PFMEA and maintain risk management program.

Skills

Root Cause Analysis

Corrective Action

Preventive Action

SPC

QSR/ISO/MDD/MDR knowledge

Risk Management

Bilingual English/Spanish

Education

Bachelor’s degree in engineering or equivalent

Tools

DOE

ANOVA

Regression Analysis

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

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 (preferred).

Functions and Responsibilities

• Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and technology transfers.
• Lead the product and process transfer; responsible to meet the transfer due date, smooth transfer without major quality issues.
• Responsible for developing and maintaining the quality and monitoring the manufacturing documentation to comply with our standards.
• Support the Quality Engineer Manager and Quality Manager in the budget activities.
• Investigates the root cause of quality problems and complaints using statistical techniques (DOE, ANOVA, Regression Analysis, etc.).
• Improve manufacturing, inspection, and test documentation to ensure that customer requirements are met.
• Ensure GMP regulations and ISO and corporate guidelines are followed.
• Responsible for the technical Supervisor on the In-Process Inspection of their assigned lines.
• Responsible for analyzing areas of opportunities (NC) for their areas and assure that the action taken is to focus on root cause and proposing new methods to improve manufacturing process.
• Evaluate customer complaints received from Divisions.
• Responsible for opening of Quality Events Identify areas of opportunity within the facility.
• Identify and implement cost Improvement project and quality system improvements.
• Assist in conducting quality audits to ensure compliance with BD procedures and specifications.
• Participate in third party audits such as corporate, ISO and FDA.
• Design methods and procedures to improve inspection and testing for manufacturing and engineering.
• Perform other duties as assigned by management.
• Identify and Implement Poka-yokes on their Assigned lines to reduce Inspection on the process and Improve processes on the manufacturing lines.
• Perform Process Failure Mode Effect Analysis (PFMEA) and maintain the risk management program to ensure compliance with local and global procedure

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills

Required Skills Optional Skills .

Primary Work Location

MEX Reynosa

Additional Locations Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.