Description
**Job Description**
1.0 GENERAL OBJECTIVE:
Design, maintain, and optimize systems and processes related to technical documentation, inventory traceability, and operational support, ensuring quality standards, efficiency, and regulatory compliance. Provide comprehensive technical support to departments including Quality, Production, Warehouse, Import/Export, Marketing, Sales, and Printing Room, collaborating closely with local and global teams. Actively participate in engineering change implementation, continuous improvement initiatives, validations, and strategic projects, with a focus on operational innovation, data analysis, and structured process improvement.
2.0 RESPONSIBILITIES / FUNCTIONS:
Responsible for generating, ensuring, and executing MCORs.
Responsible for designing Work Instructions at the Finish Good level.
Support interpretation of Work Instructions design at the Finish Good level.
Support translation of design, customer specifications, Quality Alerts, and Medline requirements for Work Instructions at the Finish Good level.
Implementation and support of CAPAs.
Responsible for resolving discrepancies in engineering C\-Hold orders.
Responsible for ArtWork design.
Participate in audits.
Participate in project implementation.
Map and maintain AS400 and MPOWER system locations to improve picking efficiency.
Analyze and update critical high-demand part numbers to enhance production efficiency.
Design and implement standardized work instructions and visual aids, and facilitate technical training to ensure adherence to established procedures.
Administer personnel classification and user profile maintenance in ProTrack and AS400 systems.
Provide technical support to operational staff in the ProTrack system.
Generate ideas for continuous improvement, process optimization, and resource utilization.
Support the development and updating of documented procedures via the ETQ Reliance platform.
3.0 PROFESSIONAL PROFILE:
3.1 Experience / Technical Knowledge
3.1.1 Minimum 1 year of experience in the medical industry related to Quality, Production, Engineering, or Surgical Activities.
3.1.2 Bilingual (English–Spanish) at 85%\~(B2 level).
3.1.3 AS400, Minitab, Macros, AutoCAD, Adobe, M\-Power, Pack Draw, Microsoft Office (Project, Excel, Word, PowerPoint, Outlook) (advanced).
3.1.4 (Desirable) Basic knowledge of ISO\-13485 Medical Devices Quality Management Systems.
3.1.5 (Desirable) Basic knowledge of ISO\-11607 Packaging for terminally sterilized medical devices.
3.1.6 (Desirable) Basic knowledge of ISO\-5356 Anaesthetic and respiratory equipment.
3.1.7 (Desirable) Basic knowledge of computer system programming.
3.1.8 Knowledge of warehouse safety protocols and practices.
3.1.9 Knowledge of Lean Manufacturing/MKOS tools.
3.1.10 Knowledge of methods, time, and motion studies.
3.1.11 Ability and knowledge to understand and perform transactions in AS400.
3.1.12 Project implementation using Kaizen, PDCA, and Improvement Idea techniques.
3.2 Competencies / Soft Skills
3.2.1 Teamwork, data interpretation, determination, proactivity, results orientation, sense of urgency, leadership, effective communication, people orientation, negotiation skills.
3.2.2 Decision-making leading to positive outcomes based on analysis.
3.2.3 Availability across shifts. Always responsible and professional.
3.3 Academic Background
3.3.1 Completed Engineering/Degree program. Preferred fields: Surgical Nursing, Industrial Engineering, Systems Engineering, Mechanical Engineering, or Mechatronics.
3.3.2 Green Belt (Desirable).
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.