Essential Duties and Responsibilities :
Responsible for the following areas
Quality Engineering Activities (including Inspectors)
Quality Records retention and storage
Sustaining / improvements quality system
Establishing, maintenance and publishing metrics that shows indicators of performance of the facility on product.
Responsible for identifying any gap on the Quality System and verify it is corrected.
Being part of the Internal Audit team.
Establish and maintain activities oriented to Continuous Improvement.
Responsible for establishing periodic meeting to evaluated and dispose the material on MRB.
Responsible for coordinated the response to Corrective Actions Request from Customer on the time frame establish by each customer.
Establish and execute the Annual Internal Schedule.
Experience of 2 years on similar positions on the medical industry sector.
Experience on ISO 13485.
Knowledge of FAD QSR 21 CRF Part 820 and Part 11.
Language Skills :
English Proficiency Required.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills :
Able to perform basic math calculations.
Perform statistical reports and analysis.
Reasoning Ability :
Ability to solve logical problems.
Ability to solve practical problems.
Ability to handle interpersonal conflicts
Other Knowledge, Skills, and Abilities :
You must have an intermediate level of software management (Outlook, Excel, Word, Power Point.)
Able to develop interpersonal relationships with all levels of the company.
Being able to perform Transactions, generated reports on ERP system.
Manage statistical software analysis, such as Minitab or JMP.
Physical Demands :
Physical demand can Require
Occasionally standing, walking, reaching things with your hands and lifting weights less than 25 pounds.
Requires this sitting, use hands to point, handle or sit, and speak or hear.
Work in moderate sound environments.
Education & Experience Requirements :
Industrial Engineer, or any other engineer related field.