- Internationally recognized/respected product line that pushes medical boundaries
- Work with Director level leaders in an environment that promotes upward mobility
About Our Client
Our client is a complex class III OEM that manufactures state-of-the-art surgical devices. Due to the complexity and accuracy of their product line, our client sets the industry standard for their niche market. They are regularly recognized by the media due to their heartwarming success stories.
The Senior Quality Systems Engineer will...
- Maintains and improves QMS
- Recommends and implements potential improvements or enhancements to quality systems and processes
- Leads the Quality Audit system by managing the audit schedule and participating in and leading internal audits
- Leads Quality aspects of the Supplier Management process
- Supports external and internal audits
- Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews
- Manage CAPA
- Maintains SOP Training for the Company; ensures employees are assigned appropriate training plans
- Ensures compliance of QMS through SOP updates and training
- Identifies product and process improvements; leads and supports their implementation
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The Senior Quality Systems Engineer will have...
- Project management experience
- Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
- Experience in medical device manufacturing and EtO sterilization of disposable medical devices
- Experience with Quality Auditing to 21 CFR Part 820 and ISO 3485.
- Excellent track record trouble-shooting and applying effective, systematic problem-solving methodologies
- Ability to communicate ideas and information clearly, effectively and concisely
- Six sigma training/certification is a plus
- Experience creating and working with databases, queries and reports is a plus
What's on Offer
The selected Senior Quality Systems Engineer will recieve...
- Competetive compensation package
- Hybrid work model
- Work on state-of-the-art class III medical devices used in hospitals nation-wide
- Work on nationally-recognized products
All qualified candidates can expect feedback within 48 hours. Please reach out to Cameron Cyker for more information.