The Quality Engineer at C2Dx is an entry-level position with pathways to becoming a significant contributor to the Quality Assurance team. In this role, you will be a critical team member contributing to the execution of the company strategy for an evolving medical device company. This role will provide Quality System improvements with significant time spent troubleshooting, diagnosing failure modes, and recommending solutions for customers. You will be expected to work alongside cross-functional management teams and support our products, services, and Quality System.
C2Dx is a medical device company based in Kalamazoo, Michigan, that invests in and refines the delivery of valuable, niche products to propel their growth and accessibility worldwide. Founded in early 2019 by industry experts, C2Dx is committed to providing leading medical products and superior customer service, while continually evolving to ensure that healthcare providers have the devices and technology they need.
- Understand areas of responsibility according to C2Dx Quality Management System
- Execute Quality and Regulatory strategies to enhance profitability
- Primarily responsible for the development support and maintenance of the quality management system processes in accordance with relevant regulatory requirements
- Research, organize, and draft business process maps and knowledge layer documents
- Work on cross-functional teams and collaborate with partners in the Organization to document and clarify processes
- Support Supplier Evaluation and Supplier Audits
- Help process owners and SMEs navigate the Document Management Process
- Managing the preparation, review, and submission of pre-market submissions, technical files, and design dossiers, including establishing and maintaining necessary written procedures, such as for submission review, applications, CE marking and clearance. (US and OUS compliance)
- Serve as a Regulatory representative on new product development and sustaining engineering project teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions
- Responsible for reviewing and approving product and manufacturing changes for compliance with applicable regulations, and developing and implementing departmental and divisional policies and procedures to ensure assessment of significant changes
- Drive a culture of safety and efficacy through Quality tools such as 6S
- Support Internal Audit, CAPA, Nonconforming Product Procedure, Customer Feedback and Complaints, Vigilance, and other duties as required by Management
- Continually provide and contribute towards company and process improvements to the C2Dx Quality Management System
Qualifications and Skills
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
- Bachelor’s degree required with 1-3+ years of relevant experience in similar roles
- STEM background preferred
- Prior experience in a regulated environment desired
- Prior experience managing projects and change management is preferred
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- This is a salaried, non-exempt position that will require occasional evening work, and correspondence with customers, distributors, and regulatory bodies outside of normal working hours
- Travel not to exceed 25%
- A candidate may need to occasionally push, pull, or lift 25-50 lbs
- Frequent walking, standing or sitting for extended periods of time
Please submit your resume to firstname.lastname@example.org