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Senior Quality Engineer at SoTalent Senior Quality Engineer at SoTalent in Hudson, Massachusetts Posted in about 2 hours ago.

Type:

full-time Senior Quality Engineer ????

Location:

Hudson, MA ????

Industry:

Staffing and Recruiting ????

Work Setting:

Onsite 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. 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. Key Responsibilities Quality Systems & Regulatory Compliance Quality Management System (QMS) 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.

Regulatory Compliance Support compliance with:

FDA 21 CFR

Part 820 ISO 13485 ISO 14971 Medical Device Quality Regulations Risk Management Standards Design Controls & Risk Management Design Control Activities Oversee Design History Files (DHF). Support design verification and validation activities. Ensure compliance with design control requirements throughout development. Risk Management 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. Process Validation Manufacturing Validation Lead and approve: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Validation Engineering Develop validation protocols and reports. Support manufacturing process improvements. Ensure validated processes meet quality and regulatory requirements. Statistical Analysis Utilize methodologies such as: Statistical Process Control (SPC) Design of Experiments (DOE) Process Capability Analysis Root Cause Analysis Quality Operations Non-Conformance Management Investigate and manage Non-Conformance Reports (NCRs). Drive timely resolution of quality issues. Monitor recurring trends and systemic problems. CAPA Management Lead Corrective and Preventive Action (CAPA) activities. Conduct root cause investigations. Verify effectiveness of corrective actions. Failure Investigations Analyze product and process failures. Conduct detailed investigations and documentation. Recommend corrective and preventive solutions. New Product Introduction (NPI) Product Development Support Partner with R D teams during product development. Ensure quality requirements are incorporated early in design. Support design reviews and product transfer activities. Change Management Evaluate quality impact of engineering changes. Support product modifications and process changes. Ensure proper documentation and risk assessments. Cross-Functional Leadership Stakeholder Collaboration Work closely with: Research & Development Manufacturing Engineering Regulatory Affairs Operations Teams Supplier Quality Teams Technical Leadership Provide quality expertise on business-critical projects. Influence product and process decisions. Drive quality-focused decision making across teams. Audits & Inspections Internal Audits Support and participate in internal quality audits. Assess process compliance and effectiveness. Recommend improvement opportunities.

External Audits Support:

FDA Inspections Certification Audits Supplier Audits Customer Audits Audit Readiness Maintain inspection-ready documentation. Address audit findings and observations. Drive continuous compliance improvements. Required Qualifications Education Bachelor's Degree in: Mechanical Engineering Biomedical Engineering Manufacturing Engineering Quality Engineering Related Technical Discipline Experience 5-8+ years of experience in: Medical Device Industry Quality Engineering Regulated Manufacturing Environments Product Quality Systems Technical Skills Quality Systems FDA Quality System Regulations (QSR)

ISO 13485 ISO 14971 FDA 21 CFR

Part 820 Quality Management Systems (QMS) Design Quality Design Controls Design Verification Design Validation DHF Management Risk Management Validation

IQ/OQ/PQ

Process Validation Test Method Validation Statistical Analysis Quality Operations

CAPA NCR

Management Root Cause Analysis Failure Investigations Continuous Improvement Key Skills Quality Engineering Medical Devices FDA Regulations

ISO 13485 ISO 14971

Design Controls

DHF CAPA NCR

Process Validation

IQ/OQ/PQ

Risk Management