EPM Scientific has partnered with a global pharmaceutical company that is looking for a Quality Engineer II to join their Medical Device function on a contractual basis.
The Quality Engineer II will have the following responsibilities:
- Working along side a team with a focus on qualifying equipment, developing test methods, verifying design, and validation testing
- Providing Quality oversight to ensure processes are aligned with quality standards and compliance
- Ensuring device testing, method development, and method transfers follows compliance
- Reviewing and approving characterization, feasibility studies, test method development/validations
- Supporting the development of device plans
- Draft and approve Quality Agreements for equipment vendor, method developers, and service providers
The Quality Engineer II will have the following qualifications:
- Experience with design verification methods
- Knowledge of regulatory and compliance requirements for medical devices
- Experience working in a GLP environment
- Bachelor's Degree in Scientific or Engineering related discipline
- 5+ years of experience in pharmaceutical or medical device industries
- 3+ years of experience in cGLP/GMP experience
Starting on a 12 month contract
This role is HYBRID in New Haven, CT - with an expectation to be onsite 3 days/week
Benefits including health, vision, dental insurance & 401k available
