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YOUR TASKS AND RESPONSIBILITIES

• Responsible to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels.
• Promote the implementation and maintenance of procedures to verify, validate and control the manufacturing process in order to ensure that specified product requirements are met.
• Manage the quality assurance group to include the following processes:
  • Quality Control: In-process & final inspections & testing, Incoming Inspections, First article & R&D inspections, Engineering Testing, Complaints Investigations, Post-sterilization testing.
  • Quality Assurance: Quality Metrics Reporting, Non-conforming material reports & deviations, CAPA, Internal, external & supplier audits, Material Review Board (QMRB), Equipment Calibration.
  • Quality Systems: Document Control, Change Management (BASICS & SAP), Final product release, PM & CAL task management, Document approval (Heredia & LRM), Training, Control of External Standard & GSOP’s.
  • Projects & Validations: Environmental Monitoring, Clean room, re-qualifications, Sterilizer re-qualifications, Quality & Technology transfer plans, Process validations, Aging & Biocompatibility.
• Responsible to establishment of suitable processes and organizational structures and responsibility for related changes in the QMS. Take actions plan to promote continues improvement of the QMS. Demonstrate the suitability and effectiveness of the manufacturing process. Act as Head of Quality and Quality Management Representative for Bayer Medical QMS.
• Promote the creation of quality plans due to technology transfer projects, validations and significant changes in the QMS as applicable. Establish guidance and maintain Documented Quality Plans to ensure a timely and controlled implementation of product developments, improvement projects and sub-contracted manufacturing activities. Oversee the establishment of the essential quality aspects of a product, such as safety, performance, reliability and compliance with regulatory and customer needs during the product life cycle.
• Change Control Management – Promote the definition of standards and processes for the control of documents, records and master data according to Bayer requirements. Determine measurements for substantial and non-substantial changes in liaison with other Bayer functions.

WHO YOU ARE

• Technical degree in Quality Control (Desirable).
• Bachelor degree in Industrial Engineer or similar.
• Minimum of 3-5 years of experience in the Quality Assurance department or production of a medical device company required.
• Knowledge of federal and International medical device regulations is required.
• Knowledge of Good Manufacturing Practices (GMPs).
• High Level computer knowledge (Excel, Word, Power Point, VISIO, e-mail, change control, SAP, project, Master Control).
• Demonstrate ability to communicate verbally and in writing at a level commensurate with regulatory and technical reporting requirements.
• Knowledge of ISO 13485 & FDA auditing requirements.
• Languages: English level (Advance), Spanish (Native).