Quality Engineer II

About the role

We are seeking a Quality Engineer to join a growing medical device contract manufacturing organization. This role is a key part of the Quality team, working closely with Engineering, Manufacturing, Operations, Suppliers, and Customers to ensure compliance, drive continuous improvement, and maintain a robust Quality Management System. The position is fully onsite with a 4x10 schedule from Monday to Thursday and is contract-to-hire.

Responsibilities

• Maintain and improve Quality Management System (QMS) processes in accordance with FDA QMSR, ISO, and applicable regulatory requirements.
• Own and drive CAPA, nonconformance, complaint handling, and corrective action activities.
• Review quality trends and escalate recurring issues into formal quality investigations when appropriate.
• Serve as a quality representative during customer interactions related to complaints, investigations, and quality concerns.
• Partner with Engineering, Manufacturing, Operations, and Supply Chain teams to drive issue resolution.
• Plan, conduct, and support internal, supplier, customer, and regulatory audits.
• Manage supplier quality activities including supplier qualifications, monitoring, corrective actions, and audits.
• Lead quality training initiatives and educate employees on quality system requirements and best practices.
• Mentor junior quality personnel and develop organizational quality competencies.
• Utilize Excel, Power BI, and other reporting tools to analyze quality metrics and trends.
• Monitor performance indicators and identify opportunities for process improvement.

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• Minimum 4+ years of Quality Engineering experience within a regulated medical device environment.
• Strong knowledge of FDA QMSR, ISO, CAPA Systems, Nonconformance Management, Complaint Handling, Change Control, Root Cause Analysis, and Quality Risk Management.
• Experience conducting or supporting internal, supplier, customer, and regulatory audits.
• Strong understanding of Quality Management Systems and electronic QMS platforms.
• Experience working cross-functionally with Engineering, Manufacturing, and Operations teams.
• Strong verbal and written communication skills.
• Ability to work independently and drive projects to completion with minimal supervision.
• Training and mentoring experience.

Qualifications

• Medical device contract manufacturing experience.
• Supplier audit experience.
• Customer-facing quality experience.
• Front-room audit support experience.
• Regulatory affairs exposure including FDA submissions, 510(k) processes, or product registration activities.
• Validation experience including IQ/OQ/PQ.
• Experience with Power BI, NetSuite, SharePoint, or electronic QMS platforms such as TrackWise, MasterControl, Greenlight Guru, QT9, or similar systems.