Quality Lead Specialist

WIPRO GE HEALTHCARE PRIVATE LIMITED

5 - 10 years

10 - 11 Lacs

bengaluru

Posted:9 hours ago| Platform:

Apply

Skills Required

remediation product engineering interpersonal skills process improvement qms failure analysis regulatory compliance healthcare total quality management individual contributor

Work Mode

Work from Office

Job Type

Full Time

Job Description

Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms for all aspects of functional responsibility.
Supports continuous product and process improvement through detailed failure analysis for nonconformance and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
Impacts projects, processes, and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance.
Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.
A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others.

Required Qualifications

This role requires 6 plus years of experience in a Quality & Healthcare Quality role in a regulated industry (such as ISO13485, FDA, EUMDD/MDR) with a thorough understanding of the regulations and standards.
Knowledge level is comparable to a Bachelors degree from an accredited university or college (or a high school diploma with relevant experience).
Years of experience in the relevant industry 5 to 10 Years or more

Desired Characteristics

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.
Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820, IEC 62304-2006 (Medical Device Software), and ISO 13485.

More Jobs at WIPRO GE HEALTHCARE PRIVATE LIMITED

Staff Software Engineer

Bengaluru

9.0 - 14.0 yrs

INR 7 - 11 Lacs

Area Sales Manager

Gurugram

4.0 - 8.0 yrs

INR 5 - 9 Lacs

Sr Staff Enterprise Architect

Bengaluru

12.0 - 17.0 yrs

INR 20 - 25 Lacs

Software Engineer

Bengaluru

2.0 - 7.0 yrs

INR 4 - 9 Lacs

Sr Staff Enterprise Application Engineer

Bengaluru

10.0 - 12.0 yrs

INR 25 - 30 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.