Job Description: SUMMARY: Coordinates the activities of a group of quality inspectors, receipt inspectors, and quality assistants, ensuring they perform their activities within the indicated standards and procedures. Additionally, carries out improvement projects in the area, follows up on administrative activities, and communicates with other departments inside and outside the company to receive and send various information as required. SPECIFIC JOB DESCRIPTION: QUALITY SYSTEM Generates and updates department procedures.
Ensures compliance with current department procedures.
Generates and updates controlled formats.
Ensures compliance with good manufacturing practices in the area.
Ensures compliance with company regulations in the supervised areas.
INSPECTION PROCESS Defines, implements, improves, and clarifies inspection methods.
Analyzes the causes of defects reported by inspectors and defines disposition.
Makes decisions on non-conforming and rejected products and materials under an MRDR (Rejection Form) and determines the applicable final disposition.
Implements corrective and preventive actions as required.
Files rejections and other applicable documents.
SUPERVISION Prepares and timely distributes various reports (production rejections [weekly], rejections and receipts [monthly], GMPs [monthly]).
Meets weekly with quality inspectors to inform.
Informs and provides feedback to inspectors on rejections and customer complaints.
Verifies and confirms staff payroll with HR.
Manages shift, schedule, and/or area movements of the staff in charge.
Manages vacations, permits, and vacations of the staff in charge.
Provides the necessary equipment for associates to perform their daily activities.
Resolves different problems of the associates in charge.
Purchases necessary equipment and tools for the quality inspector's operation and the position itself.
Periodically evaluates staff.
Evaluates and strengthens staff training needs with different strategies.
Job Requirements: Professional, preferably Industrial or Mechanical Engineer.
Knowledge of Quality System, ISO 13485 Standards.
Desirable experience in medical processes, molding, and/or electronics.
Internal auditor training (desirable).
Desirable communication in English at least 60%.
Service attitude.
Skills to work with staff in charge and teamwork.
Operating Company:
SparkThe Spark Clear Aligner System is manufactured by Ormco, a global leader in innovative orthodontics products. Spark aligners are made with TruGEN, the latest innovation in clear aligner material. In the same way that Spark is designed to give orthodontists more control and flexibility, our careers are designed to give you more control and flexibility. Working at the intersection of technology and patient needs, you'll be positioned to drive disruptive thinking and spark your career.
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