Supplier Quality Engineer

Posting Date 1 month ago(9/21/2021 8:41 AM)
Requisition ID
2021-9573
Job Location(s)
Vandergrift PA United States
Travel
None
Position Type
Full Time
Company
Cook Vandergrift
Category
Quality

Overview

Ensure consistent quality of products provided by Cook suppliers and ensure suppliers comply with CVI QMS requirements.

Responsibilities

• Develop and maintain robust supplier quality program
• Lead supplier quality investigations; Draw from supplier expertise
• Support / lead supplier quality audits
• Provide supplier quality performance metrics to Management Review

• Integrate risk management into all facets of supplier quality and management
• Review new and revised material and product purchasing specifications
• Oversee supplier change management
• Resolve incoming quality inspection supplier discrepancies

• Conduct supplier quality investigations
• Purchased product nonconformance meeting (MRB representation)
• Resolve incoming quality inspection supplier discrepancies
• Provide/coordinate engineering support to the incoming inspection function
• Manage SCARs; SCAR Sponsor or team member Supplier Development
• Develop and monitor supplier performance metrics for trends
• “QBR” review of quality improvement opportunities
• Lead, sponsor, or complete assigned, related CAPAs
• Perform or concur with QE risk assessments
• Define and refine IQC requirements (alignment with supplier)

Qualifications

• Bachelor's degree in a technical discipline

• Knowledge of medical device regulations, pertinent standards and guidances
• 5 years of Supplier Quality experience preferred
• Auditor certification (ASQ or equivalent) is preferred
• Proficient in Microsoft Word/Excel/Outlook

 

Physical Requirements:

• Works under general office environment conditions
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to sit, stand, walk, and communicate

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