Quality Engineer - Medical Devices | NPI & Process Validation

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

Job summary

Actalent is seeking a Quality Engineer in Anoka, MN, to drive new product introduction, design transfer, and manufacturing transfer activities within a regulated medical device environment.

The role focuses on project management, CAPA, FMEA/DOE, and ensuring compliance with FDA regulations while collaborating with engineering, operations, and suppliers to enable a smooth transition from development to production.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Quality Engineering experience within medical device or regulated manufacturing environments.
• Experience with new product introduction, 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

FDA Regulations

Risk Management

CAPA

SPC

FMEA

Root Cause Analysis

Project Management

Communication

Quality Engineering

DOE

MSA

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

JMP

Job description

Actalent is seeking a Quality Engineer in Anoka, MN, to drive new product introduction, design transfer, and manufacturing transfer activities within a regulated medical device environment.

The role focuses on project management, CAPA, FMEA/DOE, and ensuring compliance with FDA regulations while collaborating with engineering, operations, and suppliers to enable a smooth transition from development to production.