Director, Post Market

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief QARACA Officer

Description

Key Responsibilities

• The Director of Post Market Quality Assurance is responsible to develop, lead, and direct a Quality Assurance team that manages the key post market QMS Processes indicated in the purpose section above.
• Responsible for identifying and resourcing improvement programs to ensure suitability and compliance to all applicable Medical Device regulatory regulations and standards. 
• Oversees the timely collection, analysis, and reporting of all post market quality signals to determine the need for escalation, correction and removal, or corrective/preventive actions. 
• Responsible for managing communication to the FDA and international regulatory agencies for post-market surveillance activities (i.e., complaints, adverse event and incident reporting, recalls, and field safety corrective actions). 
• Prepares inputs to the required Management Reviews per the policies and procedures established. 
• Leads key QMS Projects that drive improvements in process efficiencies and effectiveness while assuring compliance to Medical Device Regulations. 
• Monitors and advises Senior Management of Medical Device regulation and standard changes to assess the impact to the QMS. 
• Provides cross functional support with other Team Leaders to implement continuous improvements projects in a timely manner. 
• Reviews and approves applicable QMS documentation pertaining to Product Correction/Removal and post market quality processes. 
• Provides guidance and training of GMP requirements to company employees on an annual basis. 
• Ensure company documentation meets the required guidelines for maintaining FDA Medical Device compliance, ISO, and other applicable domestic and international regulations 
• Facilitates cross functional collaboration in implementing post market quality related activities. 
• Key member in supporting third party, customer and regulatory audits as required. 
• Practice Advita's Values. 
• Know and apply CFR Part 820 Medical Device Quality System Regulations, CFR Part 806, CFR 803 and ISO 13485:2016 requirements and any other applicable Federal and International standards. 

Skills Knowledge and Expertise

•  Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred 

•  RN or similar healthcare certification preferred. 
• Minimum 10 years’ experience in FDA/ISO medical devices or equivalent quality management system regulations required 
• Minimum 5 years experience technical writing skills for healthcare, science or quality management systems required 

•  Working knowledge of windows-based office productivity tools including word processor and spreadsheet 
• Excellent verbal and written communication skill 
•  Detailed oriented with strong organizational skills 
• Self-directed, capable of helping establish cross functional priorities and working collaboratively to meet established deadline 
• Ability to understand, coordinate and implement technical documentation effectively with individuals and cross functional teams to improve the timely completion of projects