Director, Post Market

Director, Post Market

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief QARACA Officer

Description

The Director Post Market Quality Assurance provides leadership and direction in ensuring the sustainability of an effective and compliant Quality Management System (QMS) Post Market QA program, that includes the following key processes:

• Post Market Surveillance
• Product Correction and Removal Program (Field Safety Notices, Recalls, etc)
• Complaint Management
• Vigilance Reporting
• MDR reporting
• Recall reporting
• EUDAMED reporting

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

Education:

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

Experience:

• 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

Functional/Technical Knowledge, Skills and Abilities 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