Sr Quality Engineer -Medical Device (Class III)- Reading, Ma

As the Sr QE you will maintain and enhance the Quality Management System-managing document control, driving CAPA investigations through root cause analysis and verification of effectiveness, and supporting both internal and external audits. You will also analyze quality performance metrics, collaborate across teams to address non-conformances and supplier issues, and lead process improvement initiatives to ensure compliance with ISO 13485.

Client Details

This pioneering medical-technology company has developed the Organ Care System (OCS)-a portable, FDA-approved perfusion platform that maintains donor hearts, lungs, and livers in a near-physiologic, functioning state outside the body-dramatically extending preservation time, enabling real-time viability assessment, and increasing organ utilization compared to traditional cold storage methods.

Description

• Maintain and support the QMS to ensure compliance, including CAPA, non‑conforming material reports, supplier controls, risk reviews, and management review activities.

• Execute and coordinate the CAPA program-handling investigations, documentation, metrics, trends, and quality input.

• Coach CAPA Owners in problem‑solving techniques such as Root Cause Analysis, DOE, and FMEA.

• Oversee the internal audit program-scheduling, closing findings, and reporting metrics.

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

• Develop and analyze quality metrics for monthly reviews and Management Review.

• Offer cross-functional QA support throughout the organization.

• Lead and contribute to risk management and FMEA initiatives.

• Drive quality system improvements-creating/revising documentation and closing compliance gaps.

• Identify and escalate critical quality issues to leadership with supporting data and recommendations.

• Train and guide staff on quality systems, procedures, and best practices.

• Support quality planning, processes, and special projects as needed.

• Perform additional duties and tasks as assigned.

Profile

• 5-7+ years of experience in quality systems.
• Strong CAPA ownership experience.
• Skilled in SOP creation and internal auditing.
• Experience with EQMS implementations and system validation.
• CMDCP or internal auditor certified (not required but a plus).
• Proactive, eager to grow with the company!

Job Offer

• Work Model: 5 days onsite
• Startup energy with corporate stability
• Transparent leadership
• Friendly, approachable environment
• Lots of opportunity for small wins and visible impact
• Recently acquired an aviation company

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.