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Quality Assurance Specialist

Company: Praxis Medical Devices
Location: Tampa
Posted on: July 15, 2019

Job Description:

Praxis Medical is led by Dr. John Fisher, the inventor of the Bio-Sentry Tract Sealant System and the HydroMark Breast Biopsy Marker. Praxis seeks to hire a Quality Assurance manager or director that is excited to bring Dr. Fisher's newest device to market. In this role, you will provide QA leadership across key departments in the development of an electronic medical device. You'll also enjoy highly competitive compensation and flexible work environment. Join our startup at the ground floor to lead our global product quality and regulatory efforts. Responsibilities:Own and maintain the company's quality management system and ensure the company is prepared for regulatory inspection (FDA, Notified Body, international regulatory bodies, corporate) at all times.Provide QA leadership and guidance across key departments on quality system standards such as 21 CFR 820 and ISO 13485.Manage quality control, quality assurance, calibration, complaint handling, document control, and employee training.Ownership of the Corrective / Preventive Action (CAPA) system and direct investigations to resolve complaints and non-compliance instances. Implement corrective action plans to correct non-compliance issues.Author and compile technical files for new products and regulatory submissions.Oversee post-market activities. Requirements:Extensive working knowledge of 21 CFR 820 and ISO 13485.A thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.5+ years experience in quality systems compliance; medical devices regulatory submissions (e.g. 510(k) and CE mark) experience is a plus.High attention to detail -- completing the "Attention to Detail" assessment is a prerequisite. Desired Characteristics:Familiarity with engineering and manufacturing processes related to electronic devices.Self-sufficient and able to work and make decisions independently.Strong problem-solving skills.Ability to manage multiple, competing priorities simultaneously.Collaborative, team-first attitude - maximizing team performance and value ideas on their merits.Ability to collaborate with team members under pressure and iterate quickly.Strong interpersonal and leadership skills.Superior verbal and written communication skills.

Keywords: Praxis Medical Devices, Tampa , Quality Assurance Specialist, Other , Tampa, Florida

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