Job Description
Senior Quality Engineer
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📍 Location: Hudson, MA
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🏢 Industry: Staffing and Recruiting
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💼 Work Setting: Onsite
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Are you a quality professional with expertise in FDA regulations, ISO standards, design controls, risk management, and process validation? This role offers the opportunity to partner with R&D, Manufacturing, and Regulatory Affairs teams to ensure products meet the highest quality, safety, and compliance standards throughout the product lifecycle.
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The ideal candidate will have deep experience supporting medical device products, quality systems, validation activities, risk management, and continuous improvement programs in a regulated environment.
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Key Responsibilities
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Quality Systems & Regulatory Compliance
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Quality Management System (QMS)
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- Ensure compliance with FDA Quality System Regulations (QSR).
- Maintain adherence to ISO 13485 quality management requirements.
- Support implementation and continuous improvement of quality processes.
- Ensure compliance with regulatory and internal quality standards.
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Regulatory Compliance
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Support compliance with:
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- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- Medical Device Quality Regulations
- Risk Management Standards
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Design Controls & Risk Management
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Design Control Activities
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- Oversee Design History Files (DHF).
- Support design verification and validation activities.
- Ensure compliance with design control requirements throughout development.
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Risk Management
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- Develop and maintain risk management files.
- Lead risk assessments in accordance with ISO 14971.
- Evaluate product and process risks throughout the lifecycle.
- Implement risk mitigation strategies and controls.
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Process Validation
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Manufacturing Validation
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Lead and approve:
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- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
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Validation Engineering
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- Develop validation protocols and reports.
- Support manufacturing process improvements.
- Ensure validated processes meet quality and regulatory requirements.
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Statistical Analysis
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Utilize methodologies such as:
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- Statistical Process Control (SPC)
- Design of Experiments (DOE)
- Process Capability Analysis
- Root Cause Analysis
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Quality Operations
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Non-Conformance Management
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- Investigate and manage Non-Conformance Reports (NCRs).
- Drive timely resolution of quality issues.
- Monitor recurring trends and systemic problems.
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CAPA Management
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- Lead Corrective and Preventive Action (CAPA) activities.
- Conduct root cause investigations.
- Verify effectiveness of corrective actions.
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Failure Investigations
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- Analyze product and process failures.
- Conduct detailed investigations and documentation.
- Recommend corrective and preventive solutions.
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New Product Introduction (NPI)
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Product Development Support
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- Partner with R&D teams during product development.
- Ensure quality requirements are incorporated early in design.
- Support design reviews and product transfer activities.
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Change Management
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- Evaluate quality impact of engineering changes.
- Support product modifications and process changes.
- Ensure proper documentation and risk assessments.
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Cross-Functional Leadership
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Stakeholder Collaboration
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Work closely with:
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- Research & Development
- Manufacturing Engineering
- Regulatory Affairs
- Operations Teams
- Supplier Quality Teams
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Technical Leadership
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- Provide quality expertise on business-critical projects.
- Influence product and process decisions.
- Drive quality-focused decision making across teams.
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Audits & Inspections
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Internal Audits
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- Support and participate in internal quality audits.
- Assess process compliance and effectiveness.
- Recommend improvement opportunities.
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External Audits
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Support:
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- FDA Inspections
- Certification Audits
- Supplier Audits
- Customer Audits
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Audit Readiness
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- Maintain inspection-ready documentation.
- Address audit findings and observations.
- Drive continuous compliance improvements.
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Required Qualifications
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Education
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Bachelor's Degree in:
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- Mechanical Engineering
- Biomedical Engineering
- Manufacturing Engineering
- Quality Engineering
- Related Technical Discipline
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Experience
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5-8+ years of experience in:
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- Medical Device Industry
- Quality Engineering
- Regulated Manufacturing Environments
- Product Quality Systems
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Technical Skills
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Quality Systems
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- FDA Quality System Regulations (QSR)
- ISO 13485
- ISO 14971
- FDA 21 CFR Part 820
- Quality Management Systems (QMS)
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Design Quality
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- Design Controls
- Design Verification
- Design Validation
- DHF Management
- Risk Management
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Validation
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- IQ/OQ/PQ
- Process Validation
- Test Method Validation
- Statistical Analysis
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Quality Operations
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- CAPA
- NCR Management
- Root Cause Analysis
- Failure Investigations
- Continuous Improvement
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Key Skills
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- Quality Engineering
- Medical Devices
- FDA Regulations
- ISO 13485
- ISO 14971
- Design Controls
- DHF
- CAPA
- NCR
- Process Validation
- IQ/OQ/PQ
- Risk Management
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