Associate Specialist Quality

Wipro Enterprises; Bengaluru; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

GE HealthCare is a leading global medical technology and digital solutions innovator. The role focuses on building a Quality culture, ensuring regulatory compliance, and driving quality metrics across products and sites in the healthcare domain.

The candidate should have advanced experience in Quality and Regulatory, a bachelor’s degree, and proven skills in internal audits, process improvement, and project management within the medical device or pharmaceutical manufacturing sectors.

Qualifications

• This role requires advanced experience in the Quality & Healthcare Quality and a bachelors degree from an accredited university or college.
• Minimum 3 years in Quality and/or Regulatory
• Good Knowledge on Medical Device Standards and Regulations
• Qualified internal auditor (ISO 9001, ISO 13485)
• Worked in Medical device or Pharma Manufacturing industry.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs.
• Established project management skills.

Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region and manages the quality management system for the business.
• Utilizes professional judgement to solve problems and communicate with stakeholders.
• Executes and drives quality objectives, metrics, reporting and operating mechanisms.
• Implements and maintains quality and regulatory compliance while improving process effectiveness and efficiency.

Skills

Quality management

Regulatory compliance

Medical device standards

Internal audit

Communication skills

Project management

Problem solving

Education

Bachelor's degree in a relevant field

Job description

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

• GEHC ONLY 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. 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.
• 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.

Required Qualifications

• This role requires advanced experience in the Quality & Healthcare Quality and a bachelors degree from an accredited university or college .

• Minimum 3 years in Quality and/or Regulatory

• Good Knowledge on Medical Device Standards and Regulations

• Qualified internal auditor (ISO 9001, ISO 13485)

• Worked in Medical device or Pharma Manufacturing industry.

• Strong oral and written communication skills.

• Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs.

• Established project management skills.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to

race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected

veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver

with focus, and drive ownership - always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into

world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and

scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

Additional Information

Relocation Assistance Provided: No