Quality Specialist
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
We are looking for a driven Quality Assurance professional to support quality and compliance activities across the product 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
. 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.
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
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Additional Information
Relocation Assistance Provided: No
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
