Vacancy expired!
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. Description The responsibilities of the Senior Quality Engineer will include: Implement and maintain company quality system in compliance with applicable FDA, ISO-13485, CE and other regulatory requirements as well as with internal policies and procedures Establish tools to monitor quality processes and ensure corporate processes adhere to quality standards Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Prepare reports on status of quality system on a regular periodic basis and present at management review meetings Serve as quality representative on cross-functional teams working with design engineers to provide quality input for new product development. Ensure appropriate quality planning and procedures for new products, design changes and process modifications Review and provide feedback on project deliverables including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports. Generate deliverables such as quality plans, risk management documents (e.g., hazard analysis, design failure mode and effect analysis), design validation and usability. Ensure that design controls are compliant with all relevant regulations (FDA, 13485). The successful candidiate will have the following Bachelor's Degree in Engineering Experience in the Medical Deic e Industry Laser Technology experience will be highly valued Design Control experience Our client is a Medical Device Start-up working on a Proof of Concept in the Laser Technology Industry. They have a brand new facility located right in Waltham, MA. Our client offers a competitive salary, bonus, and benefits. Once you apply I will reach out and share more information.
Vacancy expired!