GE HealthCare Uppsala Quality Leader 

Sweden 

360170320

As the Quality Leader in Uppsala, you'll develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. Has in-depth knowledge of ISO 13485, process controls, and quality management systems. Can establish best practices and knows how own area integrates with others; has work experience in heavily regulated industry.Will be responsible for ensuring and maintaining quality management system requirements are met throughout product life cycle. This will include supporting and performing internal and external audits, writing quality records, partnering with R&D teams on investigations, ensuring timely and complete records, and overseeing final product release operations.
Responsibilities

• GEHC Creates a Quality culture by driving compliance activities around a specific product and site. This includes being responsible for the total quality management system for the business and driving Quality metrics.

• Ensures quality and regulatory compliance while driving process effectiveness and efficiency.

• Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.

• Has awareness of latest functional developments in own area.

• Contributes towards strategy and policy development, and ensures delivery within area of responsibility.

• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

• Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment.

• Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Required Qualifications

• This role requires significant experience in Quality & Healthcare Quality. Knowledge level is comparable to a Master's degree from an accredited university or college in a technical field (or a high school diploma with relevant experience).

• Familiar with root cause analysis, problem solving, and building Corrective and Preventive Action (CAPA) plans

• Demonstrated ability to analyze complex problems and build and execute resolution plans.

• Strong oral and written communication skills both Swedish and English.

Desired skills

• Strong interpersonal and leadership skills.

• Demonstrated ability to analyze and resolve problems.

• Demonstrated ability to lead programs / projects.

• Ability to document, plan, market, and execute programs.

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.