Quality Assurance Manager

A Day in the Life Directly Monitoring the QA KPI s and help team achieve that, team management, OU team Interactions; Make in India (when we plan to proceed) , Managemnt review meeting presentation draft and support to present to ILT. All QA doc. accuracy & record maintenance, Post Market issues Management, product complaints analysis on priority to SAE, planning the internal Audit and supporting for external audit. Managing NC & CAPA in Trackwise. Change control as QMS, Put Patient First Champaign; QA Stakeholder Mngt. (SCM, GDQ, TSC), directly handling FCA commencement follow up & monitoring to meet deadline. Responsibilities may include the following and other duties may be assigned.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 11s to guide performance management and employee development efforts and manage toward departmental goals. DIFFERENTIATING FACTORS Autonomy Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.
Provides tactical and / or operational leadership and coaching.
Receives assignments in task and objective oriented terms. Organizational Impact Establishes operational plans and implements policies and strategies.
Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
May have budget or P&L accountability for a department, function or geography.
Strive for continuous improvement and consistency in deliverables. Innovation and Complexity Proposes modifications to functional operating policies and day-to-day processes.
Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. Communication and Influence Communicates with internal and external customers and vendors regarding ongoing operations.
Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties .
May interact on issues that have externally shared objectives. Leadership and Talent Management Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream.
Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.
Authorizes hiring, firing, promotion and reward within own area. Required Knowledge and Experience Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Benefits & Compensation About Medtronic