Sr. Quality Engineer- Tewksbury, MA

This Senior Quality Systems Engineer role focuses on managing and improving Quality Management System (QMS) processes, including CAPA, internal audits, and quality metrics, within a fast-paced medical device environment. The ideal candidate will ensure regulatory compliance, lead risk management initiatives, and drive continuous quality improvements across the organization.

Client Details

The company specializes in developing advanced medical technologies aimed at improving patient outcomes in critical care. It values innovation, quality, and collaboration to drive continuous improvements in healthcare solutions.

Description

What you will do as a Sr. Quality Engineer:

• Manage and support Quality Management System (QMS) activities, including CAPA, audits, and supplier controls to ensure compliance.

• Lead the CAPA program by coordinating investigations, documentation, and reporting of quality metrics and trends.

• Oversee the internal audit program, scheduling audits, tracking findings, and ensuring timely corrective actions.

• Provide subject matter expertise during external audits and regulatory inspections.

• Develop and analyze quality metrics for management reviews and continuous improvement initiatives.

• Identify and implement quality system process improvements and provide training on quality procedures.

Profile

What you will need as sr. Quality Engineer:

• Bachelor's Degree in Engineering, Biomedical Science, or a related technical field preferred.

• 5-7 years experience in medical device quality systems or product quality roles.

• Proficient knowledge of 21 CFR Part 820, ISO 13485, and EU MDR regulatory standards.

• Experienced in writing and documenting quality procedures and processes.

Job Offer

What is in it for you:

• Opportunity to work in a fast-paced, innovative medical device environment focused on improving patient outcomes.

• Engage in meaningful quality system work that directly impacts product safety and regulatory compliance.

• Collaborative and inclusive workplace culture that values continuous learning and professional growth.

• Exposure to cutting-edge quality management practices and cross-functional teamwork.

• Comprehensive benefits package including health insurance, retirement plans, and paid time off.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.