Quality Engineer

Description

Position Summary

We are seeking an experienced Senior Quality Engineer to support and enhance Quality Management System (QMS) compliance within a regulated medical device manufacturing environment. This individual will play a key role in maintaining and improving quality systems, supporting internal and external audits, managing supplier quality initiatives, driving CAPA activities, and collaborating cross-functionally with Engineering, Manufacturing, and Regulatory teams. The ideal candidate is highly self-motivated, thrives in a fast-paced environment, and takes ownership of identifying and resolving quality and compliance issues with minimal direction.

Quality Systems & Regulatory Compliance

Maintain and improve Quality Management System (QMS) processes in compliance with FDA QMSR, ISO 13485, ISO 9001, and ISO 14971 requirements. Support regulatory activities including FDA submissions, 510(k) documentation, design controls, risk management, and change management processes. Lead and support preparation for FDA, ISO, customer, and third-party audits.

Audit Management

• Plan, conduct, and report internal quality audits.
• Lead supplier audits and supplier quality assessments, including travel as required.
• Support external regulatory and customer audits by coordinating responses, evidence collection, and corrective actions.

Quality Operations

• Manage CAPA, non-conformance, complaint/customer feedback, and investigation activities.
• Facilitate Material Review Board (MRB) and CAPA Review Board meetings, ensuring effective follow-up of actions and deliverables.
• Lead root cause investigations and implementation of corrective and preventive actions.
• Support engineering change control and document control activities.

Validation & Risk Management

• Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ activities.
• Support risk management processes and design control deliverables throughout the product lifecycle.
• Analyze quality trends and metrics to identify improvement opportunities and reduce risk.

Cross-Functional Leadership

• Coordinate activities across Engineering, Manufacturing, Regulatory Affairs, and Quality functions.
• Provide quality leadership on product and process improvement initiatives.
• Deliver training and coaching to personnel on quality systems, compliance requirements, and best practices.

Reporting & Analytics

• Utilize Excel, Power BI, and PowerPoint to analyze quality data and create meaningful reports and dashboards.
• Track KPI performance, audit findings, CAPA effectiveness, supplier performance, and QMS health metrics.