Supplier Quality Engineer
$73.1k - $120.2kBio-Techne
Bio-Techne seeks a Supplier Quality Engineer to manage supplier performance, conduct audits, and ensure compliance with regulatory standards across manufacturing and supply chain operations. The role combines quality engineering expertise with supplier relationship management to support product quality and operational efficiency.
Responsibilities
- Qualify and onboard new suppliers through capability assessments, audits, and quality evaluations
- Manage supplier performance, requalification activities, and Approved Supplier List maintenance
- Lead Supplier Corrective Action Requests (SCARs) including root cause review and verification
- Conduct supplier and internal audits for ISO 13485, ISO 9001, MDSAP, and regulatory compliance
- Support production part approval processes (PPAP) and new product introductions
Requirements
- Bachelor's degree in Engineering or related technical discipline
- 2-5 years of Supplier Quality, Quality Engineering, or Process Engineering experience
- Experience in regulated manufacturing (Medical Device, IVD, Biotechnology, or Pharmaceutical)
- Knowledge of root cause analysis, corrective action processes, and quality improvement methodologies
- ASQ CQE, CSQP, Six Sigma Green Belt, or equivalent quality certification
- Internal Auditor or Lead Auditor certification experience
- Working knowledge of cGMP, ISO 13485, and FDA-regulated manufacturing environments
Compensation: $73,100.00 - $120,200.00
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