Quality Engineer - Medical Devices | NPI & Validation

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

Benefits offered by this job

PTO

401K match

10 Paid Holidays

Job summary

Actalent is seeking a Quality Engineer to support new product introduction, design transfer, validation, and manufacturing transfers. You will collaborate with engineering, operations, suppliers, and customers to ensure quality and regulatory compliance across development to production.

Ideal candidates bring 5+ years in quality engineering within regulated manufacturing, strong CAPA/FMEA experience, and proficiency with Minitab/JMP. On-site role in Minneapolis, MN with benefits.

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.

Job description

Actalent is seeking a Quality Engineer to support new product introduction, design transfer, validation, and manufacturing transfers. You will collaborate with engineering, operations, suppliers, and customers to ensure quality and regulatory compliance across development to production.

Ideal candidates bring 5+ years in quality engineering within regulated manufacturing, strong CAPA/FMEA experience, and proficiency with Minitab/JMP. On-site role in Minneapolis, MN with benefits.