Quality Engineer II

Title:

Quality Engineer II (NPD/Sustaining)

Duration: 3 months to start

Location:

Fully onsite in Devens, MA (hours are 8am-5pm with an hour lunch)

Rate - $45-50/hr

Our client is a medical device manufacturer looking for a Quality Engineer II to provide support for a large project installation. They are specifically supporting the development of a combination product.

• Provide Quality Engineering and Validation support for the Program Managers on customer programs as required
• Automated production line validation
• Time out of refrigeration / time out of environment.
• Review daily rejects and implement or discuss action plans
• Manage and investigate customer complaints
• Manage CAPAs
• Make appropriate changes in documentation as required
• Make appropriate changes to fixtures or inspection methods
• Create/Maintain FMEA's, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocol's, PPAP's as appropriate
• Manage, analyze, and create reports for Process Capability studies, FAIR's, GR&Rs, and other data before sending to customer
• Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions
• Participate in internal and supplier audits
• Participate in design reviews

• Medical Device/Combination Product Experience
• Quality Engineering
• New Product Development
• Sustainability
• IQ/OQ/PQ
• FMEAs