Quality Specialist

Posted 14 Days Ago
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Uppsala, SWE
In-Office
Junior
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
The Quality Specialist will support quality and compliance activities throughout the product lifecycle, maintain the quality management system, engage in audits, and promote continuous improvement in collaboration with teams.
Summary Generated by Built In
Job Description SummaryWe are looking for a driven Quality Assurance professional to support quality and compliance activities across the product lifecycle. In this role, you will help maintain the Quality Management System, support key quality processes, contribute to audit readiness, and work closely with cross-functional teams to promote continuous improvement and ensure compliance with applicable standards and procedures.
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 Description
Responsibilities
  • Foster a strong Quality culture by promoting compliance throughout the product lifecycle and supporting the execution of quality objectives.

  • Support the implementation, maintenance, and continuous improvement of the QMS.

  • Develop and maintain QMS documentation in alignment with GE HealthCare procedures, ISO 13485, and applicable regulations. Assess and support implementation of local impact from global changes to GEHC procedures.

  • Support and review non-conformances, investigations, and corrective and preventive actions (CAPA) as QA.

  • Manage Site Quality training activities.

  • Participate as the Quality representative in New Product Introductions (NPI) as a core team member, reviewing design and development documentation.

  • Participate as the Quality representative on the Production and Process Change Review Board, providing quality input and reviewing proposed changes.

  • Support internal and external audits, contributing to audit readiness and compliance activities.

  • Provide QA guidance and support to other functions.

Required Qualifications
  • M.Sc. in Life Sciences, Biomedical Engineering, or related field.

  • Solid QA experience within the medical device industry.

  • Solid knowledge and experience working with ISO 13485.

  • Strong communication and interpersonal skills.

  • Demonstrated ability to analyze issues and support problem-solving activities.

  • Excellent communication skills in English and Swedish, both spoken and written.

Desired Skills
  • 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.

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.

#LI-MG1

Additional Information

Relocation Assistance Provided: No

Top Skills

Iso 13485
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The Company
Chicago, IL
50,282 Employees
Year Founded: 1892

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.

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