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.
M.Sc. in Life Sciences, Biomedical Engineering, or related field.
Some experience in a QA role 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.
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.
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.
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Relocation Assistance Provided: No