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:

- Technical degree: Bachelor of Science or higher

- 5+ years of experience in a Quality role within an FDA regulated environment, medical devices preferred

- Experience leading FDA and internal audits. Ability to explain and defend QMS structure and documents.

- Demonstrated knowledge of FDA's 21 CFR 820

- Know-how with cleanroom manufacturing/assembly is a plus

- Experience writing and following approved procedures

- Very good understanding of Quality and Risk Management processes in medical device manufacturing companies

- Highly motivated with the ability to work on own initiative, very good analytical mindset and agile mindset

- Strong communication and leadership skills, team spirit and transformational leadership style

- Professional written and verbal communication skills, strong presentation skills

- Independent and efficient work style, eagerness to take on new responsibilities

- Forward-thinking approach, team player, reliable, hands-on approach

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

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