Senior Quality Engineer – Medical Devices (CAPA & SPC)

Regulatory Jobs; Olive Branch (MS); Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

Highridge Medical is seeking a Senior Quality Engineer I to drive quality processes across the product lifecycle. You will lead MRB/NCR activities, perform root cause analysis, and oversee IQ/OQ/PQ and validation efforts for inspection equipment and processes.

The role requires 5+ years in Quality Engineering, GA AP standards familiarity, and strong skills in PDP, CAPA, and SPC. Collaboration with R&D and Operations is essential to support new products and lifecycle management.

Qualifications

• 5+ years in Quality Engineering.
• Strong knowledge of GD&T and measurement systems.
• Experience with MRB/NCR, CAPA, and root-cause analysis.
• Familiarity with QSR/ISO regulations, PFMEA, and product testing methods.

Responsabilités

• Utilize quality tools to develop, transfer, and maintain products throughout lifecycle.
• Lead MRB/NCR processes and perform root cause analysis.
• Perform IQ/OQ/PQ related to inspection equipment and validation protocols.
• Generate KPI metrics and report to management; drive CAPA and continuous improvement.
• Collaborate with R&D and Operations on new product development and lifecycle management.
• Write/review/approve validation protocols, reports, and change orders.
• Apply statistical methods to analyze data and improve process capability.

Connaissances

Problem solving

GD&T

Team collaboration

Quality engineering

Statistical methods

Regulatory knowledge

Communication

Formation

B.S. in engineering or CQE

Description du poste

Highridge Medical is seeking a Senior Quality Engineer I to drive quality processes across the product lifecycle. You will lead MRB/NCR activities, perform root cause analysis, and oversee IQ/OQ/PQ and validation efforts for inspection equipment and processes.

The role requires 5+ years in Quality Engineering, GA AP standards familiarity, and strong skills in PDP, CAPA, and SPC. Collaboration with R&D and Operations is essential to support new products and lifecycle management.