- Join fast growing and innovative team working on Biosurgery platform
- Flexible to Hybrid work environment(2-3 days on-site a week)
About Our Client
My client is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents. The team is Cranston which is hiring focuses on a complex Biosurgery platform for the medical market.
The key responsibilities of the Senior Quality Engineer are
- Provide quality engineering leadership and support for NPD, transfer to manufacturing and sustaining engineering for Class II and III devices and combination products.
- Collaborate with cross-functional groups comprising product development, quality, regulatory, clinical, manufacturing operations, and marketing to develop, communicate, and measure progress against goals for project/program success.
- Develop Protocols and Reports to support Regulatory 510K, PMA, CE mark and international registrations.
- Provide leadership/input into Product Development Plans (PDP), Design Input Summary (DIS), Product Performance Specification (PPS), Design verification/validation protocols/reports, biocompatability and stability testing including analysis of data and communication of results.
- Establish relationships with suppliers, CMO and CTL to ensure quality of materials, components and services.
- Develop/maintain risk management files, coordinating input from the other Design Sub-team members, and manage overall risk files throughout product life cycle.
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 successful Senior Quality Engineer will have:
- Bachelor's Degree in Engineering or Technical Sciences.
- Minimum of 5 years relevant experience in medical device industry with a BS or, minimum of 4 years relevant experience with MS.
- Experience in product development and/or product life cycle sustaining activities in the surgical, biological or disposable medical products or related industries.
- A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.
What's on Offer
My client offers a competitive base, bonus potential, work from home flexibility, and world-class benefits. If you are interested please apply to the below link.