Sr Engineer Sterilization

Location: Nuevo Laredo, Tamaulipas

Remote Type: On-site

Time Type: Full time

Job Description

Job Description

General Objective:

Provide quality assurance and technical sterilization support to the terminal sterilization of medical devices and other healthcare products. The position will support the
Medline Product Divisions and external customers in order to maintain compliance to regulations and industry standards including 21 CFR Part 820, ISO11135 and ISO13485.
Ensure product processing, regulatory requirements, and equipment requirements are met in accordance with specifications including calibrations, internal, customer and regulatory audits, validations, record keeping and reporting.

Responsabilities:

• Monitor trending and data relative to quality system and make recommendations for improvement as well as establish implementation plans. Prepare reports for monthly, quarterly, and semi-annual trending and host monthly Quality Review Board meetings with Management.
• Perform or facilitate the review and maintenance of equipment calibration and qualification records per established procedures. Maintain equipment calibration and qualification schedules for the facility to ensure activities are completed within specified time frames.
• Review preventive maintenance records to ensure they are completed as scheduled. Review unscheduled maintenance and initiate/review equipment change control documentation to ensure process equipment remains in its validated state.    
• Host internal and external audits including customers and regulatory bodies. Represent the facility on matters pertinent to the Quality Management System as established through regulations, industry standards and procedures. Assist audit team in vendor audits as needed for technical support.
• Work with plant employees and management to identify root cause and implement corrective actions as required due to process deviations, complaints, and audits. Develop responses and interact with customers or regulatory agencies related to audit findings or requests.
• Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution. Maintain sterilization files and document libraries.
• Facilitate the maintenance of local training documentation for plant employees. Develop training materials and train employees in response to procedural change, policy changes and improvement activities.
• Create and update procedures, Quality System Forms, Specifications and other controlled documents including sterilization process parameters as needed for improvements to the process and to maintain compliance to industry and regulatory standards.
• Prepare sterilization validation protocols and final reports. Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete multiple simultaneous EO validation activities or customer special requests with time sensitive schedules. Coordinate and assist in validation product load set up and sample/sensor retrievals.

Experiencia/ conocimientos técnicos 

• 6+ Years working in Medical Device manufacturing- required
• 6+ Years working in FDA/ISO 13485 regulated environment--required
• Design Control Process/IQ/OQ/PQ-required
• Knowledge in ISO standar 11135-Desirable
• Must be willing to work safely in environments where hazardous materials may be present
• High level skill in Microsoft Office tools.
• English

Competencias /softskills 

• Effective communication
• Proactive
• Able to manage multiple projects
• Schedule Availability
• Sense of Urgency

Formación académica 

• Bachelor Degree with a scientific or engineering background

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.