Description

Director of QA, Post-market Surveillance

General Summary:
This senior leadership role in Quality Assurance requires the candidate to steward the oversight and integrity of post-market surveillance quality systems. Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines. Areas of focus include: all aspect of Complaint Management, System Ownership, resolution and trending. Reviews, analyzes and reports on quality discrepancies related to product functionality. Submits appropriate metrics and reports to the company as part of the Management Review process.

The role also acts as a liaison between the business/region complaint management organizations as well as other company entities and various governmental agencies and notified bodies around the world to foster compliance within BSC.

Duties and Responsibilities:
? Interface division/region counterparts to ensure compliance, determine responsibilities and solutions when required.
? Works directly with colleagues on the creation of appropriate tools, processes, systems and infrastructure to ensure the execution of all aspects of post-market product surveillances from complaint initiation, processing, investigation, closure and trending to enforce requirements and meet specifications.
? Assists the rest of organization to ensure compliance with all post-market surveillance responsibilities.
? Collaborates with IT and other stakeholders on the development and improvement of systems and processes used in post-market surveillance activities. Assists with the development and execution of training for end-users on these systems and processes.
? May serve as the corporate subject matter expert related to post-market surveillance.
o Maintain compliance to procedures
o Manage and maintain effectiveness of Quality Management System in that area
o Represents the corporation to outside regulatory bodies
o Ensures submittal to the company a monthly report summarizing trend analysis on their defined and applicable quality system clauses and corresponding quality objectives via the Management Review System
o Facilitates the awareness of regulatory and customer requirements throughout the organization
? Develops and monitors department budgets
? Ensure implementation of functional excellence initiatives.
? Encourages problem-solving processes leading to leveragability of solutions across divisions
? Ensure sharing of initiatives/ideas and accomplishments across the divisions
? Responsible for succession planning and the development and implementation of retention strategies
? Proactively reviews future technologies and plans needed resources with appropriate technical skills through either external search or training to prepare.
? Coach, develop and mentor Quality employees. Allocates/re-allocates internal and external resources, as needed

Minimum Education & Experience:
Candidate possesses a B.S. Degree with a 10-14 years experience in quality and regulatory for medical devices and pharmaceuticals. 7-10 years of supervisory experience recommended. The majority of experience should be in medical devices. An advanced engineering degree or MBA is highly desirable.

Specific experience in the area of quality systems for post-market surveillance is highly desirable.

Good grasp of FDA protocol and process. ~MDC

Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings

Requirements

See Above