Job Description SummaryWe are looking for a Lead Specialist, Quality Engineer. The Lead Specialist, Quality Engineer is responsible for providing process support for our engineering and production teams in accordance with our procedures & practices. This is a key technical role responsible for the continuous development, implementation and reinforcement of our quality assurance practices. Lead Specialist, Quality Engineer is also a core member in design development and production teams engaged in development and production of high-quality medical device systems.

Job DescriptionResponsibilities

Ensures quality and regulatory compliance in accordance with documented procedures

Leads development and implementation of strategy to ensure compliance and product quality 

Ensures process efficiency and compliance

Drives, influences and supports continuous process improvement

Drives, influences and supports continuous product quality improvement

Supports CAPA process

Performs internal audits and supports external audits

Qualifications and requirement

Bachelor’s degree or advanced degree

Experience in Quality Assurance, Quality Engineering or Production Quality in medical device industry 

Demonstrated understanding of medical device QMS requirements and regulatory requirements, including but not limited to FDA CFR 21 820 and ISO 13485

Demonstrated understanding of medical device design control requirements

Demonstrated understanding of medical device production control requirements

Demonstrated knowledge of Quality and Process Improvement tools

Ability to communicate effectively in Finnish and English

Desired skills

Strong technical aptitude

Ability to handle tasks with competing priorities effectively

Demonstrated collaboration and conflict resolution skills

Analytical, problem solving and root-cause analysis skills

Change agent with energy, passion  and enthusiasm to drive change

What We Offer                  

Great opportunity to become a world class Quality Assurance professional of medical devices

Work with experienced and supportive team of colleagues

Access to world class processes and professionals across different functions

Position with possibility to influence in a diverse multicultural working environment

Possibility to try and grow into different roles in the organization

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.

Behaviours:
 

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.

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Additional Information

Relocation Assistance Provided: No