Quality System Manager

Quality System Manager

This position is full-time and reports to the President of the company.

The primary purpose of this position is to develop a strategic plan for the company's quality management system and follow, maintain, test and evolve the quality management system that governs the medical device manufacturing operations and finished products distribution. It involves the planning, implementation, improvement, and management of the quality system, as well as all interactions with relevant authorities, mainly FDA

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Plan, Follow, maintain, test and evolve the quality management system, according to FDA's 21 CFR 820
• Contact person for the Company's Management
• Leadership and responsibility for the Quality Team
• Manage FDA Audits and respond to 483 observations / warning letters / FDA requests.
• Manage and participate in all processes for Operational Controls (e.g., Change Control, Design Control, Risk Management, Supplier Qualification) and Production Controls (e.g., specifications, monitoring, calibrations, validations)
• Conduct annual supplier audits
• Manage and participate in failure and improvement processes (e.g., NCRs, CAPAs, SCARs, customer complaints)
• Manage and maintain Training Program
• Maintain records related to device design, manufacturing, and distribution
• Conduct scheduled Management Review Meetings and document these
• Ensuring the necessary Quality requirements as well as the Quality structure in the company
• Other duties as required or assigned

REQUIREMENTS / EXPERIENCE :

No sponsorship visa (H1-B, etc) candidates at this time, sorry.

Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to :

COYOTE TECHNICAL & EXECUTIVE SOURCING

Phil Montoya

Director of Sourcing

Quality Systems Manager - Atlanta area

QualityEngineer

QualityControl

QualityManagementSystems

QualitySystems

QualityAudit

Atlanta

Jobs

Manufacturing

Hiring