Quality Engineer

Quality Engineer

📍 Location: Parkersburg, West Virginia, United States

🏢 Industry: Biotechnology research

💼 Work Setting: Hybrid

Are you passionate about quality systems, regulatory compliance, root cause investigations, and continuous improvement within regulated manufacturing environments?

We are seeking a Quality Engineer III to support quality assurance activities, maintain compliance with GMP and ISO requirements, and drive quality excellence across manufacturing operations. This role serves as a quality subject matter expert, partnering with cross-functional teams to resolve quality issues, manage CAPA activities, support audits, and ensure products consistently meet regulatory and customer requirements.

The ideal candidate combines expertise in quality systems, risk management, validation, auditing, and regulatory compliance with strong problem-solving and stakeholder management skills.

Key Responsibilities

Quality Systems Management

• Serve as a Quality Subject Matter Expert (SME) for manufacturing and quality operations.
• Maintain and improve quality management system (QMS) processes.
• Ensure compliance with company quality standards and regulatory requirements.
• Support ongoing quality system effectiveness and operational excellence.

CAPA & Quality Investigations

• Lead and support:
• Corrective and Preventive Actions (CAPA)
• Deviation Investigations
• Non-Conformance Management
• Root Cause Analysis
• Identify quality issues and drive timely resolution.
• Implement sustainable corrective actions that prevent recurrence.
• Monitor CAPA effectiveness and closure activities.

Risk Management & Compliance

• Conduct risk assessments using methodologies such as:
• FMEA (Failure Mode and Effects Analysis)
• Risk-Based Quality Assessments
• Evaluate potential quality and compliance risks.
• Recommend mitigation strategies and control measures.
• Ensure quality decisions align with regulatory expectations and business requirements.

Audit Support

• Support internal, customer, and regulatory audits.
• Prepare documentation and evidence for audit activities.
• Participate in audit responses and remediation efforts.
• Track audit observations and ensure timely closure.
• Maintain inspection readiness across quality systems.

Quality Improvement Initiatives

• Lead and support continuous improvement programs.
• Identify opportunities to improve quality, efficiency, and compliance.
• Implement process enhancements that strengthen product quality and operational performance.
• Promote a culture of quality and continuous improvement throughout the organization.

Regulatory & Standards Compliance

• Ensure adherence to:
• GMP (Good Manufacturing Practices)
• FDA Regulations
• EMA Requirements
• ISO 13485
• ISO 9001
• Internal Quality Standards
• Support regulatory inspections and customer compliance requirements.
• Monitor changes in regulations and quality standards.

Validation & Qualification Support

• Support development and execution of:
• Validation Protocols
• Qualification Activities
• Process Validation
• Equipment Qualification
• Review validation documentation for quality and compliance.
• Ensure validation activities meet regulatory and organizational requirements.

Stakeholder & Customer Engagement

• Collaborate with:
• Manufacturing Teams
• Engineering Teams
• Operations
• Regulatory Affairs
• External Customers
• Regulatory Agencies
• Communicate quality issues, risks, and updates effectively.
• Influence stakeholders to support quality objectives and compliance initiatives.

Documentation & Quality Records

• Ensure accurate maintenance of:
• Quality Documentation
• Change Control Records
• CAPA Documentation
• Audit Records
• Validation Documents
• Support document control processes and quality record management.
• Maintain compliance with documentation requirements.

Qualifications

Education

• Bachelor's Degree in:
• Mechanical Engineering
• Industrial Engineering
• Manufacturing Engineering
• Quality Engineering
• Related Technical Discipline

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)

Experience

Required

• 2 years of experience in Quality Assurance within a regulated industry:
• Pharmaceutical
• Medical Device
• Biotechnology
• Experience with:
• CAPA Management
• Deviation Management
• Change Control
• Risk Management
• Internal & External Audits
• Document Control
• Experience supporting qualification and validation programs.

Technical Skills

Quality Systems

• Quality Management Systems (QMS)
• CAPA Management
• Deviation Investigation
• Change Control
• Risk Assessment
• FMEA

Compliance & Auditing

• GMP Compliance
• ISO 13485
• ISO 9001
• FDA Regulations
• EMA Requirements
• Internal Auditing
• External Audit Support

Validation & Engineering

• Equipment Qualification
• Process Validation
• Validation Protocols
• Manufacturing Quality

Analytics & Problem Solving

• Root Cause Analysis
• Statistical Analysis
• Quality Metrics
• Continuous Improvement Tools

Software & Tools

• Quality Management Software
• Microsoft Office Suite
• Reporting & Documentation Systems

Core Competencies

• Quality Assurance
• CAPA Management
• GMP Compliance
• ISO 13485 / ISO 9001
• Root Cause Analysis
• Risk Management
• FMEA
• Validation & Qualification
• Internal & External Audits
• Regulatory Compliance
• Continuous Improvement
• Quality Systems
• Change Control
• Manufacturing Quality
• Stakeholder Management