Job Description Summary

Responsible for aiding in the development, installation, and operation of the Quality System to economically control the quality of raw materials, in-process, and finished products. The role includes, but is not limited to, developing and auditing inspection criteria or methods, conducting technical and statistical investigations into quality issues and complaints, validating products, processes, and test methods, and implementing corrective actions. The incumbent is crucial in ensuring that both corporate and customer quality requirements are met in assigned areas.

Job Description

Key Responsibilities:

• Solve manufacturing and quality problems, support the manufacturing operation and responsible for quality improvement.
• Demonstrate ability to assimilate and define problems.
• Implement appropriate and efficient corrective actions to avoid problems.
• Responsible for process optimization, scrap reduction and cost reduction.

• Responsible for product and process validations within the facility and external suppliers (PQ) including testing equipment and tooling (IQ).
• 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 to develop and maintain 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 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 to analyze areas of opportunities (MRR) for their areas and assure that the action taken are to focus on the Root cause and propone new method 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 to Bard 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.
• Identify and Implement Poka-yokes on their Assigned lines to reduce Inspection on the process and Improve processes on the manufacturing lines.
• Perform other duties as assigned by management.

• 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).