Quality Engineer, Medical Devices - NPI & Validation Lead

Actalent; Minneapolis (MN); On-site; USD 95,000 - 120,000; Full time

Job summary

Actalent in Minneapolis, MN is seeking a skilled Quality Engineer to drive new product introductions, design transfer, and process validation in a fast-paced manufacturing environment.

You will collaborate with engineering, operations, suppliers, and customers to ensure quality systems, FDA compliance, and successful transfers from development to production. Experience in medical devices and risk management is preferred.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Quality Engineering experience in medical device or regulated manufacturing environments.
• Experience with NPI, design transfer, process validation, and manufacturing transfers.
• Strong knowledge of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis tools.
• Proficiency with Minitab, JMP, or similar statistical software.
• Excellent communication, analytical, and project management skills.

Responsibilities

• Represent Quality on cross-functional product development teams.
• Support design transfer and product commercialization activities.
• Review and approve specifications, validation protocols, engineering changes, and quality documentation.
• Lead or support IQ/OQ/PQ validation activities and process qualification efforts.
• Facilitate manufacturing transfers between sites, suppliers, and customers.
• Drive risk management activities including FMEAs and Control Plans.
• Partner with manufacturing and engineering teams to improve process capability and manufacturing readiness.
• Support supplier qualification, quality investigations, and continuous improvement initiatives.
• Ensure compliance with FDA regulations, quality systems, and applicable industry standards.

Skills

Quality Engineering

NPI & Design Transfer

Process Validation

FMEA & CAPA

Root Cause Analysis

Statistical Software (Minitab/JMP)

Project Management

Communication Skills

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

JMP

Job description

Actalent in Minneapolis, MN is seeking a skilled Quality Engineer to drive new product introductions, design transfer, and process validation in a fast-paced manufacturing environment.

You will collaborate with engineering, operations, suppliers, and customers to ensure quality systems, FDA compliance, and successful transfers from development to production. Experience in medical devices and risk management is preferred.