Senior Associate Specialist,Quality

GE HealthCare; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

GE HealthCare in Bengaluru seeks a seasoned professional to drive quality and regulatory compliance for medical devices. You will contribute to the QMS, ensure standards are met, and support the product and site quality ambitions.

With 5+ years of relevant experience, you will apply ISO 13485, ISO 14971, IEC 62304 knowledge and facilitate computer system validations. Strong communication and ability to work across teams are essential.

Qualifications

• Bachelor's degree required.
• 5+ years of relevant experience.
• Knowledge of ISO 13485, ISO 14971, IEC 62304 and medical device regulations.
• Awareness of software development methodologies and computer system validations.

Responsibilities

• Drive compliance activities around a product, site or region and oversee the quality management system and metrics.
• Broaden knowledge of theories, practices and procedures to execute policy/strategy within the discipline.
• Understand business drivers and how the work of the team integrates with others.
• Make decisions within a defined framework and consult more senior team members for issues outside policy.
• Explain technical information to others and communicate effectively.
• Maintain awareness of software development methodologies and computer system validations.
• Apply ISO 13485, ISO 14971, IEC 62304 and medical device regulations.

Skills

Quality management

Regulatory compliance

Medical device regulations

Quality metrics

Software validation

Education

Bachelor's degree

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). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.

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

Roles and Responsibilities

• 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. You will ensure quality and regulatory compliance while driving process effectiveness and efficiency.
• Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.
• 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.
• May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.
• A job at this level requires good interpersonal skills. Explains technical information to others.
• Candidate should have an awareness of Software Development Methodologies, Computer system validations.
• Knowledge of ISO 13485 standards , ISO 14971 standards, IEC 62304 and medical device regulations.

Required Qualifications

• Bachelor's degree from an accredited university or college
• Minimum 5+ Years of relevant experience.

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA(Food and Drug Administration) 21 CFR( Code of Federal Regulations) 820, IEC (International Electrotechnical Commission) 62304-2006 (Medical Device Software), and ISO 13485.

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.

Disclaimer

Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud

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Additional Information

Relocation Assistance Provided: No