Gerente Calidad Esterilizacion

**General Objective**:
This position is responsible for providing leadership and is assigned the authority to implement, coordinate and monitor the facility’s Quality System. Acts as the sterilization facility’s Quality Representative, ISO Management Representative, and lead Quality System contact for all activities related to the facility as directed by the Dir Sterility Assurance with a commitment towards quality, accuracy, and process improvement.

**Responsabilities**:
**Organization, Plan and Control**
- Has authority and responsibility to represent the facility on all quality matters pertinent to the Quality Management System as established through customer and regulatory requirements as well as organizational quality policies and procedures.
- Implements and communicates new or revised Quality System/Regulatory Compliance policies and procedures
- Ensures that QSR and ISO regulations are adhered to. Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.
- Ensures that all processing records are in compliance with processing specifications and Quality Systems/Regulatory Compliance requirements prior to product release. Has authority and responsibility to withhold release approval for customer product not meeting acceptance criteria. Should a question arise regarding product release or in regards to the quality of the product, service provided or regulatory issue, the issue will be discussed through appropriate management channels, ultimately to be brought before the Corporate Sterility Assurance team for resolution
- Ensures the customer processing specifications are current and readily available to the facility production staff.
- Ensures process control through review of operations, calibration, and maintenance documents. Ensures that record keeping requirements are met and that good documentation practices are followed. In addition, reviews and maintains instrument calibration and qualification documentation to ensure tests are performed according to approved procedures and schedules with acceptable results.
- Oversees that requirements are met on a continuous basis for sample transmittal related to validations or routine processing needs.
- Works with plant management to identify root cause and implements corrective actions as required due to process deviations, complaints, SCARs, CAPAs and external / internal audits. Oversees facility-training program in response to procedural changes, policy changes and improvement activities.
- Facility Quality representative during customer and regulatory audits. Provides leadership and assistance during audits to meet customer and regulatory requirements and ensure that recommendations and corrective actions are appropriate as well as efficiently acted upon and documented.
- Communicates with customer about all aspects of requirements during validation planning and execution. Oversees and coordinates validation program. Prepares validation protocols and final reports if requested by customers.
- Oversees the maintenance of the facility supplier/vendor program.
- Monitors and reports trending and data relative to Quality System and makes recommendations for improvements as well as establishes implementation plans. Generates and communicates weekly, monthly, quarterly, and annual Quality reports.
- Provides leadership, manages, monitors, and mentors Sterilization Engineers/Specialists to ensure effective performance and continual growth and development. Develops a positive learning environment, and encourages teamwork among all employees through consistent demonstration of leadership ability.
- Supports a safe, clean and secure working environment by supporting procedures, rules and regulations; supports and participates in plant safety committees. Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
- Monitors and participates in internal audits activities at facility or company level.
- Oversees the maintenance and archival of historical Quality Documents and Customer Run records.
- Maintains day-to-day Quality System operations striving for continuous improvement and cost reduction without compromising quality.
- Make decisions regarding practices and processes as a technical resource for the facility regarding sterilization practices, and standards
- Resolves customer complaints, audit observations, concerns regarding quality processing, and practices.

**Academic Requirements**

**Experience/ Technical skills**:

- A Minimum of five (5) years of experience in medical device manufacturing, pharmaceuticals, or in sterilization
operations, and Quality System FDA regulations (QSR) and validation is preferred
- ISO 13485:2016 standard and AAMI industrial sterilization methods including ISO 11135 experience preferred
and experience with statistical technique such as SPC and experimental design expe