Quality Engineer
  • Westford, Massachusetts, US
  • +914043515100
447 Days ago
Job Description

Position: Quality Engineer

Location: Westford, MA

Duration: 8+ Months contract (with possible extension)

 

Consultant must be willing to work on W2.

 

Job Description:

Quality Engineer

  • 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.

 

TOP SKILLS:

  • One is to support a Value Stream Mapping process and needs to help support the quality function.

 

CAPA knowledge

  • Quality Systems
  • Equipment
  • Calibration
  • Partnering with:
  • ME’s
  • Operations
  • Entry to Intermediate grade engineer
  • GMP
  • Lean
 
If interested, please send your detailed resume, availability date, and contact info via e-mail arif@intellectt.com to so to speed up the process.
Industry
  • NA

Required Skills
  • FDA,ISO,Quality engineer,Value Stream Mapping,Material Review Board (MRB)

Experience
  • 5+ Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h