Lead Specialist, Quality Engineer

Job Description Summary

As the Quality Lead Engineer, you will be responsible for providing engineering process support in accordance with documented procedures & practices. This is a key technical role responsible for the development, implementation, continuous improvement and reinforcement of established Quality Assurance practices. Quality Lead Engineer is also a member of one or more product development teams engaged in new product introduction and/or product maintenance relating to development of medical device systems.

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

Roles And Responsibilities

• Ensure quality and regulatory compliance in accordance with documented procedures
• Lead development and implementation of strategy to ensure compliance 
• Ensure process efficiency and compliance
• Drive, influence and support continuous process improvement
• Drive, influence and support continuous product quality improvement
• Support CAPA process
• Perform internal audits and support external audits

Required Qualifications

• Bachelor’s Degree or advanced degree
• Experience in Quality Assurance, Quality Engineering or Design Engineering in a regulated 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 software development lifecycle, software design change, software process verification and validation methodologies
• Demonstrated knowledge of Quality and Process Improvement tools
• Ability to communicate effectively in Finnish and English

Desired Characteristics

• 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 QA professional of medical devices
• Work with nice 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 & Diversity

We are proud to be an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees.

We are also proud signatories of the Armed Forces Covenant and actively welcome applications from Armed Forces Engineers, veterans, and reservists. Your skills, discipline, and experience are highly valued here.

Total Rewards

We offer a competitive salary and benefits package designed to support your ambitions and well-being. You’ll also have access to global career development opportunities in a culture that fosters innovation and support.

Ready To Make A Difference In Healthcare?

Apply now and be part of a team that’s transforming lives through technology. Creating a World where Healthcare has no limits.

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Additional Information

Relocation Assistance Provided: No