Senior Quality Engineer

Cranial & Spinal Technologies (CST) develops therapies, technologies, and procedural solutions for the treatment of disorders and injuries affecting the spine and cranial anatomy. The operating unit partners with healthcare providers worldwide to advance surgical outcomes through innovative implants, navigation, imaging, enabling technologies, and procedural excellence.

Check us out on LinkedIn: Medtronic CST

This position is based in Boxborough, Massachusetts, and supports onsite collaboration with cross-functional teams across Quality, Manufacturing, Operations, Research and Development, and Regulatory Affairs. This is an onsite role with no travel required.

The Senior Quality Engineer serves as a quality representative supporting manufacturing operations, process improvements, product quality initiatives, and regulatory compliance activities. This role partners across functions to drive product quality, ensure process effectiveness, investigate quality issues, and support continuous improvement efforts throughout the product lifecycle.

Primary Responsibilities

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
• Support root cause investigations and resolution of product, process, and supplier quality issues.
• Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
• Ensure compliance with applicable Quality Management System requirements and regulatory standards.
• Participate in risk management activities and support product and process risk assessments.
• Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.

Required Qualifications

• Bachelor's degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience.
• Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
• Experience supporting quality systems within a regulated environment.
• Experience analyzing quality data and developing effective quality solutions.
• Working knowledge of process validation, risk management, or quality engineering methodologies.

Preferred Qualifications

• Substantial experience leading and facilitating product risk management activities including Hazard Analysis, Design Failure Modes and Effects Analysis (DFMEA), use-related risk assessments, and risk/benefit analysis throughout the product lifecycle.
• Working knowledge of EN ISO 14971 and demonstrated experience applying risk management principles to medical device design, verification, validation, manufacturing, and post-market activities.
• Substantial experience with Design Controls and product development processes, including requirements management, design reviews, verification and validation, design transfer, and design change management.
• Working knowledge of EN ISO 13485, particularly Design and Development requirements (Clause 7.3), and experience supporting compliant implementation within a regulated quality system.
• Experience supporting the development, verification, and lifecycle management of complex Medical Electrical Equipment (MEE), with working knowledge of the IEC 60601 family of standards.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.