Familiarity with FDA Quality System Regulations, specifically Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management
Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
Familiarity with verification and validation requirements for a regulated product
Familiarity with requirements analysis, including development of testable and measurable specifications
Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
Spanish / English Advanced (Writing-Listening-Reading)
Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
Microsoft Office: Advanced
Oracle / Agile PLM System experience preferred but not required.
Qualifications / Calificaciones:
Ability to effectively work on project teams
Ability to effectively prioritize and coordinate project activities
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
Provide product quality engineering support for on market medical devices. This role will be responsible, with supervision, for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field.
Supports quality team in implementation of improvements or corrections based on the results of complaint investigations.
Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact.
Own Investigations and work with cross functional teams to determine if CAPA is required. Partner with cross functional team and communicate root cause, recommended changes and scope effort to implement changes as needed.
Responsible for coordinating Health Risk Assessment team with support of manager/lead when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
As applicable, supports project to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation.
