PUESTO CERRADO

Senior Quality Engineer

This position will focus on Quality system compliance and process development in the contract manufacturing of medical products.
Active participant who can manage multiple and dynamically changing projects on time, while influencing change and compliance to Quality System requirements.
Position requires skills in advanced Quality Engineering techniques including; Problem solving using Six Sigma methodology, process validations, process development and optimization, calibrations, MSA, reducing dependence on inspection, ISO 13485 and/or 21CFR820 compliance.

Roles y Responsabilidades

• Work with and lead cross functional teams utilizing the Product Development Process to ensure robust systems and controls are in place to produce defect free product while meeting business objectives and customer expectations.
• Influence change and ensure understanding and compliance to 21CFR820, ISO 13485 and the product development process
• Drive and participate in continuous improvement and process validation activities using DOE’s, FMEA’s, quality plans, calibration, MSA and other quality tools
• Work through unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on facts
• Review and approve protocols, validation documents, investigations and procedure
• Provides support by conducting investigations and assisting in data and information collection as required for quality events
• Interfaces as a subject matter expert with internal audits, ISO or other government agencies during site inspections.
• Responsible for the development of process and quality procedures.
• Implement continuous improvement methodology and metrics to improve business metrics as it corresponds
• Customer liaison for all quality related issues.
• Mentor and train other engineers/technicians/production staff in quality methodologies and regulatory requirements.
• Proactively develop improvement ideas based on experienced assessment of departmental and company performance
• Represent quality department in project team meetings and on assigned projects

Educación / Experiencia

• Minimum 5 years’ experience in a Quality Engineering role or similar for a medical device manufacturer and/or start-up company
• Bachelor’s degree preferably in Industrial Engineering, Mechanics, Chemistry or other similar
• Experience in one or more of the following topics: ISO 13485, 21CFR820, Lean Manufacturing and/or Six Sigma, CAPA, Root Cause Analysis
• CQE Certification it's a plus

Habilidades y Competencias

• Demonstrated technical writing and communication skills
• Working knowledge of Statistical software and/or Minitab