Quality Engineer III
A well known company is seeking a Quality Engineer III to join their Mansfield,MA team!
Great opportunity to join a great company.
location: Mansfield, Massachusetts
job type: Contract
salary: $48 - 58 per hour
work hours: 9am to 6pm
Update of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings.
Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements.
Ensure that all product testing data (e.g. MRI, biocompatibility) is remediated or developed to MDR standards.
Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation.
Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation. Prepare Design History files and other required supporting documentation for a notified body pilot. Provides R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records.
Bachelor's degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field.
Must have 7-10 years minimum progressive experience in leading project teams in medical device design control
Must be degreed
Must have Medical Device experience in Design Control
Shelf Life Studies
skills: Competencies Ability to work effectively in a cross-functional team environment.
High learning agility, Strong written and verbal communication and technical writing skills
Analytical approach to problem solving. Technical leadership ,strategic and tactical planning.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.