Job Description:
The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
Experience: 2-3 years minimum of Quality Engineering experience, preferrable in Medical Device Manufacturing
100% onsite role
W2 on our Payroll.
They will be a part of our post-market “Sustaining Quality Engineering” team and be supporting projects related to post-market updates to our products. This includes maintenance of risk documentation, MPIs, design change evaluations, and support of complaint investigations and analysis. This person will be expected to be prompt, organized, independent, and an aggressive problem solver. We need a candidate with a proven track record of coming up to speed quickly, strong work ethic, and a dedication to supporting life-saving medical devices.
