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Quality Engineer (Remote)

Posted 16 days ago

Position: Quality Engineer (Remote)
Location: Tarrytown, NY 10591
Term: 10 months
 
Day-to-Day Responsibilities:
  • Conduct periodic audits to verify that process capability requirements are maintained over the time.
  • Also, responsible for conducting supplier audits to ensure that documented process flow is followed, and necessary process controls are in place.
  • Drive resolution of quality issues back to the supplier. This includes customer complaints and non-conformances.
  • Ensure they are informed of and aligned around quality issue resolution.
  • Update supplier quality metrics for monthly reviews. Report on all supplier quality-related activities to assure fulfillment of requirements.
  • Participate in supplier design/engineering review & approval process, and New Product Introduction processes.
  • Support supplier selections and evaluations including determining the degree of supplier control necessary to establish compliance, based on the significance of product being purchased.
  • Provides Supplier Quality guidance within the Supplier Quality Assurance group to contribute and support key functions such as: Engineering, Manufacturing, and Procurement groups.
  • Identify systemic supplier quality issues and driving corrective and preventative actions through:
o Data and information collection regarding trends and issues.
o Data and information collection from assessments and from supply base.
o Root Cause Analysis and Problem Resolution.
  • Primarily intra organizational contacts and external contacts.
  • Provides specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated.
 
Is this a good fit? (Requirements):
  • Engineering, Mechanical Engineering, Chemistry, Biochemistry or related field.
  • Must have 3-5 years’ experience in a Supplier Quality Engineering role for a medical device or pharmaceutical company.
  • Typically 8-10 years of successful experience in related field.
  • Understanding of FDA regulations, ISO13485, EU IVDD/IVDR.
  • Travel is required for this position: potentially 20 – 30%.