Company Description Arterex/Nextphase Medical is a global, multi-capability medical device contract manufacturer specializing in Class I, II, and III single-use, electromechanical, RF bag welding, IV therapy components, and implantable devices. The company partners with medical device OEMs to deliver advanced device design, engineering, injection molding, micromolding, tooling, extrusions, and complex assembly, along with regulatory, sourcing, and logistics support. Arterex operates 16 state-of-the-art facilities with 24 clean rooms across the United States, Mexico, Italy, Ireland, and Egypt. The organization is committed to providing high-quality capabilities and services that support customers, team members, and community stakeholders. Candidates joining Arterex will contribute to innovative solutions that impact patient care worldwide.

Role Description

This is a full-time, on-site Quality Engineer role based in Mansfield MA. The Quality Engineer will oversee product and process quality across manufacturing operations, ensuring compliance with applicable medical device regulations, standards, and internal procedures. Day-to-day responsibilities include developing and maintaining quality plans, performing root cause analysis, leading corrective and preventive actions (CAPA), and supporting validation and qualification activities. The person in this role will collaborate closely with engineering, production, and supply chain teams to strengthen quality systems, reduce defects, and enhance overall product reliability. The Quality Engineer will also participate in internal and external audits, prepare quality documentation and reports, and support continuous improvement initiatives.

Duties & Responsibilities

• Understand and ensure compliance to ISO 13485, 21 CFR Part 820 and NextPhase Quality System requirements.
• Support audits performed by Notified Bodies and regulatory agencies as well as audits performed by customers.
• Perform/participate in audits of NextPhase suppliers as required.
• Act as the NextPhase quality interface for assigned customers and/or suppliers.
• Participate in the technical review of design input specifications and design documentation for new medical devices.
• Assist in the planning, development and execution of verification and validation protocols for testing of products under development.
• Conduct risk analysis for products under development and for active products as required by the customer.
• Create Quality Plans and Master Validation Plans in support of customer product implementation.
• Support existing product/process issues, including NCRs, MRB, root cause analysis, Deviations, customer complaints, failure investigations and corrective actions.
• Manage customer deliverables and quality documents to an approved/released state.
• Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhase Medical Devices LLC may from timeto-time assign to the employee.

Minimum Education and Experience: 

• Bachelor’s Degree in Engineering, Quality Assurance or related experience.
• 5-8 years in medical device quality assurance.
• Working understanding of ISO 13485 and FDA regulations, including QMS requirements for Class I, II and III medical devices.
• In-depth understanding of ISO 14971 Risk Management.

Pay Range

The annual base salary range for this position is $120,000- $125,000.