Quality Engineer

Intellectt Inc; California (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Intellectt Inc. seeks an experienced Quality Engineer with medical device industry background to support QA, manufacturing quality, product development, validation, and continuous improvement activities.

The role emphasizes FDA-regulated environments, ISO 13485, CAPA, NCR, RCA, risk management, design controls, and process validation to ensure compliant product quality and process reliability.

Qualifications

• Bachelor's degree in engineering or related field is required.
• 3+ years of quality engineering experience in a regulated environment (medical device/pharma).
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA, NCR, deviations, root cause analysis, RCCA, and change control.

Responsibilities

• Support QA activities across the product lifecycle (design, manufacturing, testing, release).
• Develop and maintain quality systems and procedures per FDA/ISO requirements.
• Lead CAPA, NCR, deviations, complaints, and corrective/preventive actions.
• Perform RCA using 5 Whys, Fishbone, and 8D methodologies.
• Support Design Controls including reviews, requirements, verification, validation, and changes.

Skills

Quality Assurance

Regulatory Knowledge

Data Analysis

Education

Bachelor's degree in Mechanical Engineering

Tools

CAPA System

Minitab

Job description

We are seeking an experienced Quality Engineer with strong medical device industry experience to support quality assurance, manufacturing quality, product development, validation, and continuous improvement activities. The ideal candidate will have hands-on experience with FDA-regulated medical device environments, ISO 13485, CAPA, NCR, Root Cause Analysis, Risk Management, Design Controls, and process validation.

Key Responsibilities

• Support quality engineering activities throughout the medical device product lifecycle, including design, manufacturing, testing, and release.
• Develop, implement, and maintain quality systems and procedures in accordance with FDA, ISO 13485, and applicable regulatory requirements.
• Lead and support CAPA, Non-Conformance Reports (NCR), deviations, complaints, and corrective/preventive actions.
• Perform Root Cause Analysis (RCA) using methodologies such as 5 Whys, Fishbone/Ishikawa, and 8D.
• Support Design Control activities including design reviews, requirements, verification, validation, and design change management.
• Develop and maintain FMEA, Risk Management files, control plans, inspection plans, and quality documentation.
• Support process validation and equipment qualification, including IQ/OQ/PQ activities.
• Investigate manufacturing and product quality issues and implement effective corrective actions.
• Partner with Manufacturing, R&D, Operations, Supplier Quality, Regulatory Affairs, and Engineering teams to resolve quality issues.
• Support supplier qualification, supplier corrective actions, incoming inspection, and supplier quality improvement activities.
• Participate in internal, external, and regulatory audits and assist with audit observations and remediation.
• Analyze quality data and trends to identify opportunities for continuous improvement and defect reduction.
• Develop and maintain process controls, statistical analysis, SPC, and quality metrics.
• Review engineering drawings, specifications, BOMs, manufacturing procedures, and inspection requirements.
• Support ECO/ECN, change control, product transfers, and new product introduction (NPI) activities.
• Ensure quality records and technical documentation are complete, accurate, and compliant with applicable procedures.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Quality Engineering, or a related field.
• 3+ years of Quality Engineering experience, preferably within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Strong knowledge of FDA 21 CFR Part 820 / applicable FDA Quality System requirements and ISO 13485.
• Experience with CAPA, NCR, deviations, complaint investigations, RCA, and change control.
• Experience with Risk Management and FMEA.
• Knowledge of Design Controls, Verification & Validation (V&V), and process validation.
• Experience working in a regulated manufacturing environment with strong documentation requirements.
• Strong analytical, problem-solving, communication, and documentation skills.