Establishes and maintains quality control standards and procedures for an area or segment. Coordinates the scheduling and control of Quality Resources, inspection activity and enforcement requirements as specified by raw materials, ingredients, product and package specifications and regulatory agencies.
Manage ongoing regulatory compliance for an area or segment, including quality systems, and customer requirements. Manage the Quality resources and functions related to projects and customer needs.
Ensures regulatory compliance with FDA QSR Part 820, ISO13485 and other applicable regulatory bodies.Applies and supports policies and procedures required for the quality system.
Ensures customer quality agreement is followed as applicable.Implements, controls, improves and reports quality performance metrics.
Responsible to support external and internal audits.Ensures all personnel reporting to the position are trained.Supervises and coordinates the quality function of Quality Engineers.
Plans and controls projects related to the quality function.Ensures that the validated state is maintained throughout any decision-making process.
Monitors and establishes action plans on cost of quality internal and external.Coordinates area department activities.Ensures measurement system performance and improvement.
Bachelor Degree (Science, Engineering).Master’s Degree (preferable).Certified Quality Engineer by American Society of Quality (preferable).
Certified Lean Six Sigma Black Belt (preferable).Certified Lead Auditor ISO13485 (preferable).Five years of experience at medical industry, as minimum.
Five years of experience in the quality engineering function, as minimum.Excellent verbal and written communication skills (Spanish and English).
Other information : Management Supervision SkillsStrong negotiation skills. Detail oriented with organizational skills.Problem solving skills and positive attitude.
Computer literate in Microsoft Office.Training / knowledge on risk management (ISO 14971).Training / knowledge on FDA QSR Part 820.