Quality Engineer - NPI & Manufacturing Transfer

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

Job summary

Actalent in Minnesota is seeking a Quality Engineer to drive new product introduction, process validation, and manufacturing transfer activities. You will partner with engineering, operations, suppliers, and customers to move products from development into commercial production, on-site in Anoka, MN with occasional travel.

This role requires strong knowledge of FDA regulations, risk management (FMEA, CAPA), QMS, and design transfer, plus hands-on experience with Minitab or JMP.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 5+ years of quality engineering experience in medical devices or regulated manufacturing.
• Experience with NPI, design transfer, process validation, and manufacturing transfers.
• Knowledge of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis.
• Proficiency with Minitab or JMP.
• 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

Medical device industry

Design transfer

FDA regulations

CAPA / FMEA

Root cause analysis

Minitab / JMP

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

JMP

Job description

Actalent in Minnesota is seeking a Quality Engineer to drive new product introduction, process validation, and manufacturing transfer activities. You will partner with engineering, operations, suppliers, and customers to move products from development into commercial production, on-site in Anoka, MN with occasional travel.

This role requires strong knowledge of FDA regulations, risk management (FMEA, CAPA), QMS, and design transfer, plus hands-on experience with Minitab or JMP.