Senior Quality & Validation Engineer — GMP/ISO Expert

GMMDC; Bartlett (TN); On-site; USD 100,000 - 140,000; Full time

Job summary

ARCH Global Precision is seeking a Senior Quality & Validation Engineer to drive quality initiatives and validation activities in a medical device manufacturing setting. The role covers all facets of quality engineering, supplier collaboration, and product verification.

You will participate in contract reviews, define inspection methods, and implement corrective actions while maintaining quality system documentation and regulatory compliance.

Qualifications

• Broad knowledge of FDA QSRs and ISO 13485.
• Proficiency with CMM, surface plate tech and inspection tools.
• Strong analytical and communication skills.

Responsibilities

• Own engineering aspects of the quality function.
• Receive and respond to customer quality inquiries with technical disposition.
• Provide training to production and engineering staff.
• Support contract review to align with supplier agreements.
• Prepare quality control plans and inspection methods.
• Participate in corrective and preventive actions.
• Assist with inspections for new products during launches.
• Maintain quality system documentation and compliance.

Skills

FDA QSR Regulations

ISO 13485

CMM and inspection

Data analysis

Communication

Education

Bachelor degree or equivalent

Tools

MS Office

Blueprints

Quality software

Job description

ARCH Global Precision is seeking a Senior Quality & Validation Engineer to drive quality initiatives and validation activities in a medical device manufacturing setting. The role covers all facets of quality engineering, supplier collaboration, and product verification.

You will participate in contract reviews, define inspection methods, and implement corrective actions while maintaining quality system documentation and regulatory compliance.