Engineer, Supplier Development Quality in Westford, MA at Volt

Date Posted: 12/7/2019

Job Snapshot

  • Employee Type:
  • Location:
    Westford, MA
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
  • Contact Name
    Volt Branch
  • Phone

Job Description

Quality Engineer, Supplier Development

Westford, MA 01886

12-month Contract, $55 - 59/hr

In this role you will be working with a world-leading medical device company.  Helping to ensure development of highest quality new products by working with R&D and manufacturing on several projects including capital equipment, single use devices, and some exciting new products and technologies as well!

Main 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.

Experience &Background Needed to Perform this Job:

  • 2 to 5 years industry experience               with medical device as a focus.
  • Bachelor’s degree, Engineering focus preferred.
  • Process Validation and Verification required, testing.
  • Experience working with systems (capital equipment and software) and working with suppliers.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications- clear & concise ideas for report writing.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Experience with Minitab or other statistics package.
  • Ability to travel approximately 10%, including internationally (possible)

Please APPLY NOW and contact Matt Haltom at (317) 599-4898 for any questions and more details regarding this position.             

Volt is an Equal Opportunity Employer