We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.
In this role, a typical day might include the following:
Reviewing design and development paperwork and records for compliance to internal procedures and regulations
Ensuring accurate justification of statistical analysis and hypothesis testing
Reviewing technical reports as well as documents for Design History Files
Participating in device risk management activities including UFMEA, DFMEA, PFMEA
Aiding in establishing statistical controls in development and transfer to manufacturing processes
Verifying data integrity, electronic data storage and data sheet validations
Reviewing and coordinating with QA Validation for all test method and design validations
Reviewing activities related to Design Verification and Design Transfer of Medical Devices
Ensuring work product meets regulations
Supporting scientific, complaint, and test failure investigations
Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis
This role might be for you if:
You have knowledge of the combination device development process
You have experience with device risk management activities
You have a quality mind-set
To be considered for this role you must hold a Bachelor’s degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:
Quality Engineer: 2+ years
Senior Quality Engineer: 5+ years
Principal Quality Engineer: 8+ years
Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.