Quality Engineer - Medical Devices (ISO/FDA) – Onsite

Actalent; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Paid time off and holidays

MN Safe and Sick Time

Job summary

Actalent is seeking a Quality Engineer to develop and improve manufacturing processes, validate equipment, and drive continuous quality improvements on the shop floor within a regulated medical device environment.

The role collaborates with QA Technicians and Inspectors to ensure compliance with ISO and FDA standards, manage customer complaints and CAPA/NCR activities, and lead change requests with customers.

Qualifications

• Bachelor’s degree in Manufacturing Engineering or a related field.
• Hands-on quality engineering experience in a regulated environment.
• Experience with FDA and ISO requirements.
• Proficiency in CAPA and nonconformance management, including root cause analysis.
• Strong quality assurance and QMS fundamentals.
• Proven ability to drive continuous improvement on the shop floor.
• Experience with GD&T blueprint reading and process capability studies.

Responsibilities

• Develop new manufacturing processes and products to meet customer and regulatory requirements.
• Create and update project-specific quality plans ensuring adherence to specifications.
• Work with cross-functional teams to support development initiatives.
• Develop methods to measure products and verify quality and performance.
• Troubleshoot measurement methods and equipment for accuracy and reliability.
• Lead product/technology validation activities (IQ/OQ/PQ).
• Manage NCRs, CAPAs, and customer complaints from creation to closure.

Skills

Quality engineering

Regulated manufacturing

CAPA/NCAR management

FDA/ISO knowledge

Root cause analysis

Statistical tools

Cross-functional teamwork

Education

Bachelor’s degree in Manufacturing Engineering

Job description

Actalent is seeking a Quality Engineer to develop and improve manufacturing processes, validate equipment, and drive continuous quality improvements on the shop floor within a regulated medical device environment.

The role collaborates with QA Technicians and Inspectors to ensure compliance with ISO and FDA standards, manage customer complaints and CAPA/NCR activities, and lead change requests with customers.