Design Quality Engineer

Qualifications
2 years of design in medical device
Med device - design controls, knowledge of external standards (EUMDR)
Risk Management - design fmeas process fmea, if there are any changes with components or design feedback loop is
Design history files
Standards assessment as well- design integrity assessment
Fundamentals of quality investigative, documentation, write-ups, eagerness to learn
Benefits
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
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
Responsibilities
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 issues
CAPAS - resolution plans, standards changes
Identify design change and work
Job description
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 issues

Must 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