QA Senior Associate Specialist

2 weeks ago

Bengaluru India GE HealthCare Full time

Job Description Job Description Summary This role involves day-today execution of QA activities including process monitoring, deviation handling, problem solving, document control, and supplier monitoring. Collaborate with cross functional team to ensure compliance with established quality standards and procedure. Work with Service providers and Channel partners to improve awareness on QMS process and procedures. Monitor supplier certification status, qualification status & performance metrics. Own Channel partners/Service providers results, drive improvements utilizing scorecards. Own Channel partners/Service providers audits, ensuring compliance, and driving improvement plans where needed. 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 Key Responsibilities: - Ensure effective implementation and maintenance of QMS procedures, Work Instructions. - Lead day to day operations ensuring adherence to Global Regulations and Standards, - Review and recommend changes to quality documentation. Ensure change controls and deviations are adequately closed. - Support internal and external audits - Lead investigations and risk assessment. - Review and analyse product complaints, non-conformances to drive CAPA. - Conduct training for quality awareness and process adherence across teams. - Monitor key quality metrics and drive performance improvements. - Liaise with Regulatory affairs on status of registration and licenses. - Work with cross functional team to foster culture of quality and continuous improvement. Desired Characteristics - Strong oral and written communication skills. - Demonstrated ability to analyse and solve problems. - Ability to document, plan, and follow program milestones. - Experience in leading and implementing a change. - Strong auditing skills. Preferred auditor in ISO 13485, ISO 9001 - Strong accountability and ability to influence without authority. Required Qualifications - Bachelor degree in Engineering - 5+ years of relevant experience in Quality Assurance preferably in Medical Devices, Pharma or Life Sciences industry. - Strong understanding of ISO 13485, FDA 21 CFR Part 820, & risk management ( ISO 14971). - Hands on experience in Supplier qualification, Audits, Change control, Document control, and validation. - Proficient in CAPA process and use of Problem solving tools. 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

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