Job Description SummaryWe are looking for a Lead Specialist, Quality Engineer. As the Lead Specialist, Quality Engineer, you will be responsible for providing process support for our engineering teams in accordance with our procedures & practices. This is a key technical role responsible for the continuous development, implementation and reinforcement of our quality assurance practices. As the Lead Specialist, Quality Engineer you are also a core member in design development teams engaged in development and production of high-quality medical device systems.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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 DescriptionResponsibilities
- Ensure quality and regulatory compliance in accordance with documented procedures.
- Lead development and implementation of strategy to ensure compliance and product quality.
- Ensure process efficiency and compliance.
- Drive, influence and support continuous process improvement.
- Drive, influence and support continuous product quality improvement.
- Support CAPA process.
- Perform internal audits and support external audits.
Qualifications and requirement
- Bachelor’s Degree or advanced degree.
- Experience in Quality Assurance, Quality Engineering or Design Engineering in medical device industry.
- Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Demonstrated understanding of medical device design controls requirements.
- Demonstrated understanding of software development lifecycle, software design change, software process verification and validation methodologies.
- Demonstrated knowledge of Quality and Process Improvement tools.
- Ability to communicate effectively in English.
Desired skills
- Strong technical aptitude.
- Ability to handle tasks with competing priorities effectively.
- Demonstrated collaboration and conflict resolution skills.
- Analytical, problem solving and root-cause analysis skills.
- Change agent with energy, passion and enthusiasm to drive change.
What We Offer
- Great opportunity to become a world class Quality Assurance professional of medical devices.
- Work with experienced and supportive team of colleagues.
- Access to world class processes and professionals across different functions.
- Position with possibility to influence in a diverse multicultural working environment.
- Possibility to grow into different roles in the organization.
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.
Behaviors
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.
Total Rewards
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.
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Additional Information
Relocation Assistance Provided: No
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What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence.
As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.
With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
We embrace a culture of respect, transparency, integrity and diversity.
