Quality Engineer – Medical Devices & Process Improvement

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

PTO and holidays

Disability insurance

Job summary

Actalent in Minnesota is seeking a Quality Engineer to drive process improvement in a regulated medical device environment. You will develop and validate manufacturing processes, manage CAPA/NCR, lead change requests with customers, and ensure ISO/FDA compliance while collaborating with QA Technicians and Quality Inspectors on the shop floor.

Responsibilities include creating quality plans, performing PFMEA and SPC studies, leading equipment validation, and generating quality KPIs to monitor

Qualifications

• Two+ years in quality engineering in a regulated manufacturing environment (five years for senior).
• Bachelor’s degree in Manufacturing Engineering or related field.
• Hands-on quality engineering with process/product development experience.
• Experience in FDA/ISO regulated environments and quality management.
• CAPA/nonconformance management with root cause analysis and corrective actions.
• Strong QA/QC principles and continuous improvement mindset.
• Experience with GMP/medical device manufacturing is a plus.
• Blue print reading/GD&T proficiency.

Responsibilities

• Develop and revise manufacturing processes to meet customer/regulatory requirements.
• Create and update quality plans ensuring customer specs and quality standards.
• Lead cross-functional teams on product development initiatives.
• Develop methods to measure product quality and verify performance.
• Lead validation activities (IQ/OQ/PQ) for new products and technologies.
• Manage NCRs, CAPAs, and customer complaints from creation to closure.
• Prepare change requests with customers for process or product changes.
• Generate quality KPIs and dashboards to monitor performance.
• Conduct PFMEA, GR&R, and SPC studies to control process risks.
• Perform internal and external audits for regulatory compliance.

Skills

Quality engineering

CAPA management

GR&R

PFMEA

SPC

GD&T

Statistical analysis

Cross-functional collaboration

Process improvement

Root cause analysis

Education

Bachelor’s degree in Manufacturing Engineering or related field

Tools

ERP system

Statistical tools

Job description

Actalent in Minnesota is seeking a Quality Engineer to drive process improvement in a regulated medical device environment. You will develop and validate manufacturing processes, manage CAPA/NCR, lead change requests with customers, and ensure ISO/FDA compliance while collaborating with QA Technicians and Quality Inspectors on the shop floor.

Responsibilities include creating quality plans, performing PFMEA and SPC studies, leading equipment validation, and generating quality KPIs to monitor