Manufacturing Quality Engineer - CAPA, RCA & CI

Katalyst Healthcares & Life Sciences; Lansing (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Manufacturing Quality Engineer to ensure product quality, regulatory compliance, and process adherence in medical device manufacturing. You will lead CAPA, perform root-cause analysis, support audits (FDA/ISO), and maintain QMS documentation (SOPs, DHF, DMR, DHR), driving continuous improvement with Lean Six Sigma.

The role requires a Bachelor's degree in engineering and strong cross-functional communication and collaboration across manufacturing,

Qualifications

• Bachelor's degree in engineering or related field required.
• Experience with medical device regulatory requirements preferred.
• Strong knowledge of CAPA, RCA and QMS documentation.

Responsibilities

• Monitor manufacturing processes to ensure product quality and compliance.
• Manage non-conformances, deviations, and CAPA activities.
• Perform root cause analysis and implement corrective actions.
• Support audits (FDA, ISO) and maintain QMS documentation.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Collaborate with cross-functional teams to resolve quality issues.
• Ensure proper documentation and traceability of records.

Skills

CAPA management

Root cause analysis

Lean Six Sigma

Regulatory knowledge

Quality systems

Education

Bachelor's degree in engineering or related field

Job description

Creative Solutions Services, LLC is seeking a Manufacturing Quality Engineer to ensure product quality, regulatory compliance, and process adherence in medical device manufacturing. You will lead CAPA, perform root-cause analysis, support audits (FDA/ISO), and maintain QMS documentation (SOPs, DHF, DMR, DHR), driving continuous improvement with Lean Six Sigma.

The role requires a Bachelor's degree in engineering and strong cross-functional communication and collaboration across manufacturing,