Experience Inc. Jobs

Job Description Summary

We are looking for a Lead Specialist, Quality Engineer. The Lead Specialist, Quality Engineer is responsible for providing process support for our engineering 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 teams engaged in development and production of high-quality medical device systems.

Job Description

Responsibilities

• 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 experience

• Bachelor’s Degree or advanced degree

• Experience in Quality Assurance, Quality Engineering or Design Engineering 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 controls 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 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

• Leader with energy, passion and enthusiasm to drive change

Eligibility requirements

Valid local work permit

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 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.

#LI-BG1

#LI-onsite

Additional Information

Relocation Assistance Provided: No