Supplier Quality Engineer

Excelon Solutions; Plymouth (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Excelon Solutions is looking for a Supplier Quality Engineer to work onsite in Plymouth, MN. The role requires a minimum of 4 years in manufacturing engineering, specifically within the medical device field.

The ideal candidate will have experience in Supplier Quality Engineering and quality tools. Knowledge of FDA regulations, GMP, and ISO standards is essential. This long-term contract position offers a chance to collaborate with suppliers and enhance product quality.

Qualifications

• 4+ years of experience in manufacturing engineering, preferably in the medical device industry.
• Experience in Supplier Quality Engineering or Receiving Inspection.
• Knowledge of FDA, GMP, ISO 13485, and ISO 14971.

Responsibilities

• Create and maintain inspection procedures and develop inspection tools.
• Support component specifications and testing.
• Investigate supplier-related field failures and lead corrective actions.

Skills

Manufacturing engineering experience

Supplier Quality Engineering

Quality tools usage

SAP familiarity

Document control systems experience

FDA knowledge

GMP knowledge

ISO 13485 knowledge

ISO 14971 knowledge

Tools

SAP

Windchill

Job description

Title: Supplier Quality Engineer with medical device

Location: Plymouth, MN - Onsite

Long-Term Contract Role

JD

• 4+ years of experience in manufacturing engineering, preferably in the medical device industry
• Experience in Supplier Quality Engineering or Receiving Inspection, including working directly with suppliers and using quality tools
• Familiarity with SAP (supply chain or quality modules) or similar ERP systems
• Experience with Windchill or other document control systems (change orders, BOM updates, etc.)
• Create and maintain inspection procedures, and develop or source inspection tools
• Support component specifications, testing, and approval for use
• Collaborate with Design Engineering on component selection, quality, and reliability
• Analyze incoming material defects and communicate issues to suppliers
• Review designs for quality and manufacturability
• Investigate supplier-related field failures and lead corrective actions
• Knowledge of FDA, GMP, ISO 13485, and ISO 14971