Edgeone Medical - Wheeling, IL
posted 5 days ago
Full-time
Wheeling, IL
Ambulatory Health Care Services
About the position
EdgeOne Medical is seeking a Quality Engineering expert to lead and oversee quality efforts for laboratory activities, including equipment qualification, test method development and validation, and testing. This role also supports quality efforts for various device and device combination product development programs, ensuring compliance with regulatory standards and quality systems.
Responsibilities
- Contribute to product development design control deliverables for client specific projects.
- Participate in coaching, training, and mentoring of EdgeOne employees and clients on quality engineering product development requirements and processes.
- Review laboratory documentation, including protocols and reports for test method validation, design verification/validation testing, and equipment qualifications.
- Oversee quality activities related to the qualification of EdgeOne Medical testing laboratory.
- Support internal and external audits, observations, responses, and applicable certifications.
- Partner with suppliers to provide necessary services for EdgeOne activities.
- Develop client relationships and personnel commensurate with their job responsibilities.
- Participate in product development activities and oversee completion of deliverables.
Requirements
- Bachelor's degree in Engineering, Life Science, or equivalent.
- 5 years of experience in a medical device quality role supporting product development or testing and TMV.
- 3 years of experience in a decision-making role for device design development, testing, or TMV.
- Thorough understanding and experience with ISO 14971, ISO 13485, and 21CFR820.
- Broad knowledge of the Product Development Processes and its supporting quality systems.
- Strong leadership, facilitation, mentoring, and communication skills.
- Strong multi-tasking and project management skills.
- Proficient with direct interactions/communications with all levels of an organization.
- Motivation and desire to share knowledge with the broader industry community.
Nice-to-haves
- Experience with supporting the development of a device from concept through launch.
- Experience with development of combination products with a device constituent.
