**Main Purpose of Job**: (Brief Summary)
- Under general direction, will perform calibration Managment duties and quality assurance support.
- Directs implementation and management of calibration analysis for equipment.
- Responsible for continuous review of FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions.
- Establishes and ensures maintenance of training programs for quality control personnel in regards to calibration.
**Responsibilities**:
- Responsible for the calibration schedule plan (execution and reporting) of all manufacturing, maintenance, facility and laboratory equipment, without any delay on the mentioned areas activities.
- Responsible for approving calibration reports, Work Request and calibration certificates by external calibration laboratories (suppliers) of all manufacturing, maintenance, facility and laboratory equipment.
- Analyze and interpret the results of calibrations using routine and specialized calculations under specific instructions and with detailed review.
- Determine if and NCR must be opened in case an Out of tolerance is detected. Verify if the equipment was calibrated using the standards and variable indicated on the applicable procedures.
- Coordinate calibrations according to business priorities (Schedule, on demands, new equipment)
- Responsible of handling, distribution and maintenance of the current and new calibration standards for the laboratory.
- Maintenance of and accuracy of all records relative to calibrations included on BM RAM System.
- Coordinate outsourcing of calibration services (locally and internationally) ensuring that all related activities are appropriately executed.
- Maintain proper documentation for all procedures and data pertaining to the area.
- Responsible of the NCR system of Out of tolerance results detected during calibrations.
- Responsible for the task's assignation / coordination of this personnel in charge.
- Train calibration Technician personnel in understanding of procedures, specifications, standards, etc.
- Participate in Internal Quality System audits including all the readiness activities.
- Write calibration procedures for different magnitudes or equipment, completes associated paperwork to ensure proper execution (training, measurement template data, etc.), interacts with customers as needed.
- Participate in Internal / External / Customer Quality System audits including all the readiness activities and documents explanation to auditors.
- Manage and lead staff (calibration technicians) to obtain company goals, including defining and communicating expectations and assignments, monitoring results, coaching, motivating and following up to achieve goals.
Education
- Minimum education required to perform duties: Bachelor degree in Engineering or Metrology, Electronics or any related field tech.
- Intermediate English level, reading comprehension and writing.
- Intermediate knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.).
- Basic knowledge in Method Validation: with emphasis on Calibration Laboratories
- Calibration Laboratories
- Basic Knowledge in Estimation of measurement uncertainty for Calibration Laboratory Personnel
- Intermediate knowledge in INTE/ISO/IEC 17025 General Requirements for the Competence of Testing and for the Competence of Testing and Calibration Laboratories
- Intermediate knowledge in Internal auditor in medical devices according to INTE/ISO 13485:2016 and INTE/ISO 19011:2018 standards.
- Basic Knowledge of Six Sigma Methodology and Lean Manufacturing.
Job Experience
- From 5 to 7 years of work experience with Calibration environment or any other area related with equipment management.
- Minimum of 5 year experience in laboratory and personnel management.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
