Engineer, Supplier Development Quality in Westford, MA at Volt

Date Posted: 2/11/2020

Job Snapshot

Job Description

Job Description

Volt Workforce Solutions is seeking an experienced Quality Engineer for our client located in Westford, Ma for a 8+ month contract. In this role candidate will provide Development/Process/Quality Engineering support of capital manufacturing equipment.  Ideal candidate will have process V&V, IQ/OQ/PQ experience. 

Responsibilities:

  • Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
  • Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
  • Responsible for creating risk analyses and FMEAs.
  • Work with design engineering in the completion of product verification and validation. 
  • Responsible for creation of test method validations.
  • Responsible for creation of Master Validation Plans and Reports
  • Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • Develop incoming inspection processes and document incoming inspection activities.
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Leads supplier development, collaborates with suppliers in resolving issues and supports supplier Change Requests.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, ISO 13485, and other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Volt is an Equal Opportunity Employer.