Senior Quality Specialist

5 days ago

Uppsala, Uppsala, Sweden GE HealthCare Full time
Job Description SummaryWe are seeking a highly motivated and experienced Senior Quality Specialist to join our team in Uppsala, Sweden. In this role, you will have a significant influence over decisions and critical QA activities. You will take on a diverse QA role, including a wide range of quality assurance activities and collaboration with several functions and Quality stakeholders in the company. This position focuses on developing and maintaining the Quality Management System (QMS), supporting operations, and managing document control to ensure excellence. The role combines both strategic and hands-on responsibilities throughout all stages of the product lifecycle.

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 DescriptionRoles and Responsibilities

  • Foster a strong Quality culture by driving compliance throughout the product lifecycle. This includes driving and executing quality objectives.

  • Lead the implementation, oversight, and continuous improvement of the QMS.

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

  • Manage non-conformances, investigations, and corrective and preventive actions (CAPA).

  • Manage Site Quality training.

  • 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 guidance and reviewing proposed changes.

  • Host internal and external audits, ensuring readiness and compliance.

  • Provide expert QA guidance and support to other functions. external sources outside of own team to arrive at decisions.

Required Qualifications

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

  • Minimum 5 years of experience in a QA role within the Medical Device industry.

  • Deep knowledge of ISO 13485 and regulatory requirements.

  • Proven experience with audits (internal and external), CAPA processes, root cause analysis, and risk management.

  • Strong analytical and problem-solving skills with attention to detail.

  • Excellent communication skills in English and Swedish, both spoken and written, with the ability to clearly articulate complex quality concepts.

  • Ability to work independently, manage multiple priorities, and meet deadlines.

Desired Characteristics

  • Deep knowledge in ISO-14971.

  • ISO 13485 Lead Auditor or similar certification.

  • Strong project management skills to manage timelines and priorities effectively.

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.

Additional Information

Relocation Assistance Provided: No

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