Design Quality Engineer

2 weeks ago


Westford, United States Mondo Staffing Full time

Apply now: Design Quality Engineer, location in Westford, MA. The start date is ASAP for this long-term contract position. Job Title: Design Quality Engineer Location-Type: Westford, MA Start Date Is: ASAP Duration: Contract Compensation Range: $35-40 Per Hour W2 The estimate above represents the candidate's typical compensation range at the time of hire. Several factors may be utilized to determine your hourly rate including but not limited to years of experience and specific skillsets compared to employees in this role. Candidates typically start at the lower half of the estimated range. This role is eligible to enroll in both Mondo's health insurance plan and retirement plan. Mondo defers to the applicable State or local law for paid sick leave eligibility. Day To Day: Document review underneath risk management Will be doing CAPAS Change Management- Making changes in the manufacturing process, end-of-life products that have to be replaced - doc reviews, change requests Interacting with R&D Identify all the qualification work, end-of-life related issues FMEAS for a medical device is a key day to day Sustaining design - end-of-life related issuesMust Haves: 2 years of design in medical device Med device - design controls, knowledge of external standards (EUMDR) CAPAS - resolution plans, standards changes Six sigma - demake- problem-solving Hands-on design V&V IQ OQ PQ Risk Management - design fmeas process fmea, if there are any changes with components or design feedback loop is Design history files Identify design change and work. Standards assessment as well- design integrity assessment Fundamentals of quality investigative, documentation, write-ups, eagerness to learn Nice to haves: Greenbelt Risk Management



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