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Supplier Development Quality Engineer

SPECTRAFORCE
Westford, MA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

Job Title : Engineer, Supplier Development Quality

Job Location : Westford, MA 1886

Job Duration : 12 Months

Job Responsibilities :

This role will primarily have 2 functions.

1st is ~

  • Working with R&D and Quality Operations teams.
  • Will need to understand how to qualify new specs on hardware and be comfortable working directly with the suppliers on qualifying new materials.
  • Need to hit the ground running with being able to read specifications, drive the control plans and drive the material qualifications with the suppliers.
  • Position is needed for new product development as launching new products in the next 18 months.
  • Must be comfortable and able to handle pressure, make decisions and again, must be comfortable working directly with suppliers / vendors.

2nd is ~

  • Handling issues on the production line as in CAPA’s.
  • The candidate needs to be able to conduct investigations and record findings with suppliers.
  • Focused on hardware ~ read specs, communicate with suppliers, and drive new material qualifications.
  • List 3-5 hard requirements for the role :
  • o Process Validation that helps us qualify new materials from the supplier.

    o Great Communication

    o CAPA around investigations.

    o Medical device exp. / knowledge

    o MUST BE comfortable speaking with Suppliers.

    o Validation of the suppliers’ materials.

  • List any preferred requirements that would stand out on a resume :
  • o Demonstrate that candidate is able to work with suppliers and relay expectations and drive the qualification of new materials.

    o Ideal would have a quality / manufacturing background or quality / regulatory background.

  • List Top Skills you are looking for ~ Deal breakers if do not have :
  • o Be able to read specifications, comfortable communicating with suppliers and come back with how to qualify materials. This would need to be actual experience so knowing how to and not being told how to.

    o Process / Product Development

    o CAPA investigations and improvements.

    Qualifications :

  • Minimum 1 year in medical device space but would prefer 1 to 3 years and internships / school projects will not be counted towards years worked.
  • Required education level / certifications : Bachelor’s in Engineering degree preferable, CQE preferable.
  • Daily tasks / duties and department interactions : Review specifications and communicate with suppliers, Complete supplier process validation and incoming inspection of new materials, Vendor and R&D calls.
  • Description of work environment / department : Supplier Quality Engineer
  • Manager is willing to review candidates who would relocate at their own expense. Please be sure to tell the candidate that they will need to be Onsite from day 1.
  • The manager wants you to focus on "strong candidates who can talk through material qualification, validations, supplier communications, problem solving through CAPAs".

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