Senior Quality Engineer

Senior Quality Engineer – Medical Device

Location: Bridgewater, MA

Employment Type: Contract

Position Overview

We are seeking an experienced Senior Quality Engineer to support a leading medical device client in the Raynham/Bridgewater, MA area. The Senior Quality Engineer will support the introduction of new technologies and products into manufacturing while providing Quality Engineering expertise across product development, validation, design transfer, and production activities.

The ideal candidate will have strong experience in medical device quality, product and process validation, risk management, and test method validation, with the ability to work effectively with Engineering, Manufacturing, R&D, Operations, Regulatory, and Quality teams.

Key Responsibilities

• Support the introduction of new technologies and products into manufacturing.
• Lead and support product and process validation activities, including validation planning, execution, and documentation.
• Develop and execute test method validation and verification activities.
• Perform and support risk analysis, including PFMEA, process risk assessments, and related quality documentation.
• Provide Quality Engineering support throughout product development, design transfer, technology transfer, and commercial production.
• Review and approve engineering and quality documentation in accordance with applicable procedures and regulatory requirements.
• Partner with Manufacturing and Engineering teams to identify and resolve process and product quality issues.
• Support root cause analysis, corrective actions, and process improvements.
• Participate in design transfer and manufacturing readiness activities.
• Evaluate process changes and assess their impact on product quality and regulatory compliance.
• Support CAPA, NCR/nonconformance, deviation, and investigation activities as needed.
• Ensure validation and quality activities are completed in accordance with applicable FDA, ISO 13485, and internal quality system requirements.
• Work cross-functionally with R&D, Manufacturing, Operations, Regulatory, Engineering, and Quality teams to ensure successful project execution.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Science, or a related technical field.
• Strong experience in Quality Engineering within the medical device industry.
• Hands-on experience with product/process validation and test method validation.
• Experience with risk management and risk analysis methodologies.
• Strong knowledge of FDA and ISO 13485 requirements.
• Experience supporting New Product Introduction (NPI), design transfer, or technology transfer into manufacturing.
• Strong technical writing and documentation skills.
• Ability to work effectively with cross-functional Engineering, Manufacturing, and Quality teams.

Preferred Experience

• Experience with process development and manufacturing process qualification.
• Experience with IQ/OQ/PQ or equivalent validation methodologies.
• Familiarity with Minitab, statistical analysis, or Design of Experiments (DOE).
• Experience with CAPA, NCR/nonconformance, change control, and complaint investigations.
• Experience working in regulated medical device manufacturing environments.