Quality Engineer: Regulatory & Process Improvement

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

Benefits offered by this job

Benefits package

401(k) plan

PTO and holidays

Job summary

Actalent in Minnesota is seeking a Quality Engineer to develop and improve manufacturing processes, validate equipment, and drive continuous improvement on the shop floor. The role leads CAPA/NCR activities, conducts QC tasks, and ensures ISO/FDA compliance within a regulated environment.

The successful candidate will work with QA Technicians and Inspectors to maintain robust quality systems, support production, and collaborate with customers and suppliers to meet quality targets and deliver

Qualifications

• Bachelor's degree in Manufacturing Engineering or related field.
• Experience in quality engineering within a regulated environment (e.g., medical devices).
• Proficiency with GR&R, PFMEA, and SPC studies.

Responsibilities

• Develop and improve manufacturing processes and products to meet customer and regulatory requirements.
• Create, update, and maintain project-specific quality plans aligned with customer specs and internal standards.
• Collaborate in cross-functional teams to support process and product development.

Skills

Quality engineering

CAPA management

NCR handling

GR&R

PFMEA

SPC studies

ISO knowledge

GD&T

Education

Bachelor's degree in Manufacturing Engineering or related field

Tools

ERP system

Job description

Actalent in Minnesota is seeking a Quality Engineer to develop and improve manufacturing processes, validate equipment, and drive continuous improvement on the shop floor. The role leads CAPA/NCR activities, conducts QC tasks, and ensures ISO/FDA compliance within a regulated environment.

The successful candidate will work with QA Technicians and Inspectors to maintain robust quality systems, support production, and collaborate with customers and suppliers to meet quality targets and deliver