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
Act as the primary coordinator for manufacturing changes, collaborating with cross-functional teams to implement engineering and production modifications effectively for NPI's , Manufacturing Transfer and existing products.
Ensure all changes are executed in alignment with Quality Management System (QMS) requirements and regulatory standards.
Participate in global and local change control meetings, initiating actions and driving timely closure of change-related tasks.
Lead local change control forums, guiding cross-functional teams to resolve issues and implement improvements.
Spearhead the implementation of QMS practices at the site level and support regulatory audits focused on change control processes.
Partner with local and global QA teams to manage nonconformities (NCs), conduct investigations, and implement corrective and preventive actions (CAPA).
Coach and mentor the Process Engineering team on QMS principles and change control procedures to build organizational capability.
Required Qualifications
Bachelor’s/master’s degree in engineering disciplines (Electrical/Mechanical/Production/Industrial/Electronics/Electronics and Telecommunication/Medical Electronics/Bio Medical Engineering).
Sound knowledge/experience of medical device Quality Management System (QMS) ISO13485, FDA regulations and Design Change control process.
Good communication skills (Oral/Written)
Effective multitasking and ability to deliver on time and with quality.
Ability to work in a team with good Interpersonal skills
Hands on experience on Microsoft office applications
Experience:
7 ~10 years in Medical Device Industry.
Desired Characteristics
ISO auditor certification
Inclusion & 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 would expect from an organization with global strength and scale, and you will be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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Additional InformationRelocation Assistance Provided: Yes
