Team Lead

Job Description / Information :

- The Team Lead shall be responsible for people management of the post market compliance and quality systems (document control) teams of Quality Assurance function. 

- Provides leadership, direction, people capabilities and ensure effective delivery of projects. Interfaces with divisional counterparts in US and elsewhere, for creating a well-defined career path and individual development plans, in sync with the business requirements and individual career aspirations.

Responsibilities:

- Define the project strategy, create project timelines with inputs from all stakeholders and monitor and control the progress of the project.

- Ensure established project management practices allow for effective, efficient and compliant development by monitoring best industry practices and integrating them into the organization

- Manage stakeholder's expectations and communicate with various functions and other project teams for the successful completion of the project

- Define, create and disseminate reports that allow evaluation the corresponding project status and progress for project staff and management

- Responsible for the timely and quality deliveries of the tasks assigned to the team

- Work as point of contact for all people related aspects with the stakeholders

- Work with stakeholders to provide inputs related to training and skill matrix

- Provide timely feedback to team members in a constructive way

- Review team progress on periodic basis and ensure timely delivery of assigned work

- Provides timely updates to Management on progress made and foreseen challenges

- Develop Individual Development plans and define performance objectives.

- Develop an open culture to instill confidence, diversity of perspectives and knowledge sharing

- Compliance to Quality Management System and Design Controls

Specific Job Skills :

- People Management

- Strong People Management skills with proven track record of leading and creating engaged teams

- Ability to influence, motivate and lead the team.

- Ability to coach team members and develop them in role.

Domain Specific / Technical :

- Knowledge of regulatory requirements: ISO 9001, Quality System Regulation and Medical Device Directive.

- Demonstrated project management experience; capability to lead teams across the U.S. and international plants to achieve global process improvement efforts.

- Experience of working with multiple teams and collaborating across geographically spread multi-functional teams

- Demonstrated experience with Word, Excel, Visio, and Microsoft Project

- Understanding of complaints handling and post market surveillance.

- Understanding of Change Control, QMS and Document control.

- Demonstrated experience processing ECNs, ECOs and procedural documentation through electronic document management systems and ERP system.

- Prefer demonstrated experience with Windchill content management system

- Demonstrated experience in training users on systems and processes within the electronic environment.

- Quality Assurance experience in medical devices preferred

- Demonstrated verbal and written communication skills

Minimum Qualifications :

Good to have:

- Knowledge of US FDA quality regulations 21CFR part 820

- Knowledge of ISO 13485 and 14971 standards

Education :

- BE/B.Tech/ME/M. Tech in Mechanical Engineering

- Experience: 8 - 12 years

- Minimum 2 years in similar role of people management

Qualifications :

- Bachelor's degree in mechanical engineering or related field from premier institutes with at least 5 years of post-market compliance and quality management systems. 

- Combination of education and experience is acceptable.

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