117 Director of QA - Medical Device  (Job ID:  117 DRA)
Miami, FL

Position Summary:

The Director of Quality will direct the overall Quality Assurance for an orthopedic company providing innovative solutions.  This position will be responsible for promoting company-wide awareness of the company’s quality policies and regulatory requirements.  This individual will also interface with FDA and EU authorities, as well as other regulatory agencies as required.  The position responsibilities will also include filing appropriate regulatory submissions, managing interal quality audits, interpret the impact of design changes on quality and regulatory adherence, and direct the handling of complaints and subsequent corrective actions.

Primary Responsibilities:

• Promote company-wide awareness of the company’s quality policies and regulatory requirements
• File appropriate regulatory submissions
• Interface with FDA, EU authorities and other regulatory agencies as required
• Manage internal Quality Audits, and implement the completion of a yearly audit schedule
• Determine the impact of design changes on quality and regulatory compliance
• Staff and train the Quality and work cross-functionally with the Regulatory Division
• Prepare and approve all quality system documents
• Direct management of tool control program
• Direct handling of compliants and subsequent corrective actions

Education Requirements:

• Bachelor’s degree in Engineering or Business

Position Requirements:

• A minimum of 10 years experience in supervision of quality and regulatory programs
• Experience with Class III Medical Devices is a must 
• Experience in designing and implementing QA/RA programs, and using that program to support company business objectives
• Experience in the production and review of quality system documents (QSPs,
  Wis, Ais, Fs, V&V reports, protocols, NPRs, SAFs)
• Work experience as a leadership team member, reporting to and collaborating with upper management
• Experience establishing quality system objectives and assignments, and delegating assignments to subordinates
• Work experience with cross-function teams
• Strong Verbal and Written Communication skills
• Demontrated ability with analysis and interpersonal interactions
• Experience using quality assurance principles to effect change
• Experience with Orthopedics is highly preferred

Salary commensurate with experience. Position is located in the
Southeast U.S.

Click here to apply online  

For additional information, please visit our website at www.LegacyMedSearch.com