Manufacturing Quality Engineer

Creative Solutions Services, LLC; 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

Job Description:

• Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.
• The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.

Roles & Responsibilities:

• Monitor manufacturing processes to ensure product quality and compliance with defined standards.
• Manage non-conformances (Client), deviations, and CAPA activities.
• Perform root cause analysis (RCA) and implement corrective and preventive actions.
• Support internal and external audits (FDA, ISO).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
• Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
• Drive continuous improvement initiatives using Lean Six Sigma methodologies.
• Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
• Ensure proper documentation and traceability of manufacturing and quality records.

Education & Experience:

• Bachelor's degree in engineering or a related field.
• Experience in medical device manufacturing preferred.
• Strong understanding of regulatory and quality systems.
• Good communication and cross-functional collaboration skills.
• Manufacturing Quality.
• GMP.
• ISO 13485.
• FDA 21 CFR Part 820.
• CAPA.
• Client.
• Root Cause Analysis (RCA).
• Risk Management (FMEA).
• Statistical Process Control (SPC).
• Audit Compliance.
• Quality Management System (QMS).
• Continuous Improvement.