QUALITY ENGINEER

hace 7 días

Reynosa, Tamaulipas, México BD A tiempo completo
Job Description SummaryFor 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 Medication Delivery Solutions (MDS) business unit aims to drive growth and innovation in everything from integrated sample management to diagnostic solutions. The Medication Delivery Solutions (MDS) unit is currently seeking.Job Description

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 procedures.

Requirements

  • 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).

BD values equity in the workplace, without discrimination against any disability, social class, ethnicity, age, religion, gender identity, or sexual orientation.

Required Skills

Optional Skills

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Primary Work LocationMEX ReynosaAdditional LocationsWork Shift

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