Quality-Validation Eng'1320

Descripción del Empleo:
Position Description: • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
Position Responsibilities :
• Coordinates and prepares document packages for regulatory submissions from all areas of company.
• Compiles all materials required in submissions, license renewal and annual registrations.
• Recommends cha
Requisitos:
Basic Qualifications Background: Educational: BS. Science, Engineering, or related field
Experience:
• 0-3 Years with Dilpoma Degree
• Exposure to compliance, configuration, documentation, quality systems, validation requirements, quality engineering, auditing, laboratory or regulatory manufacturing environment
Skills:
• Technical Writing Skills
• GMP/QMS Knowledge
• Interpersonal Relations
• Quality and Results Oriented
• Computer Literate
• Fluency speaking and writing in English and Spanish

Desired/ Preferred Qualifications
Background
• Experience in medical device, pharmaceutical, or electronic industry
• Experience in Qualification / Validation activities.
• Experience and Certification in Auditing
Skills
• Problem Solving
• Teamwork
• Communications
• Continues Improvement
• Root Cause Analysis
• Technical Writing
Alternate Job Title
Associate Regulatory Af