Quality Engineer

Quality Engineer I

The Quality Engineer I supports quality operations in a regulated manufacturing environment and ensures compliance with FDA and ISO standards. This role focuses heavily on owning CAPA activities, managing non-conformances, and executing day-to-day quality system processes. The position also contributes to cross-functional projects, process validation, risk management, and continuous improvement initiatives across Manufacturing, R&D, and Quality teams.

Responsibilities

• Lead CAPA investigations from initiation through closure, including root cause analysis, corrective and preventive action planning, and effectiveness verification.
• Review, manage, and maintain non-conformance records and other quality records, including equipment-related incidents, ensuring timely and compliant documentation.
• Support daily quality operations in a fast-paced manufacturing environment, addressing issues in real time and ensuring adherence to quality procedures.
• Participate in and help facilitate quality review boards such as Material Review Board (MRB) and CAPA review meetings, including preparing materials and tracking outcomes.
• Draft, review, and maintain validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV).
• Coordinate cross-functional activities and communications among Manufacturing, R&D, and Quality teams to resolve issues and support project execution.
• Assist with process validation, equipment qualification, risk management activities (such as FMEA), and design transfer efforts to manufacturing.
• Support ongoing quality and process improvement initiatives, including updates to quality systems, workflows, and procedures.
• Analyze quality and process data to identify trends, drive continuous improvement actions, and support decision-making.
• Contribute to internal audits and compliance activities by preparing documentation, supporting audit execution, and following up on action items.
• Review and approve quality documentation and records to ensure completeness, accuracy, and regulatory compliance.
• Coordinate meetings related to quality activities, track action items, and ensure clear communication and follow-up across teams.
• Support multiple small projects related to Quality Management System (QMS) improvements and process optimization.
• Work closely with manufacturing teams to resolve quality issues promptly and maintain product and process compliance.
• Operate effectively in a fast-paced environment with shifting priorities while managing multiple tasks and projects.

Essential Skills

• 1+ year of experience working in an FDA-regulated environment such as medical device, pharmaceutical, food and beverage, or aerospace.
• Hands-on experience leading CAPA investigations, not only supporting them.
• Experience managing or reviewing non-conformances and related quality records.
• Manufacturing experience in a regulated environment with exposure to shop floor or production operations.
• Strong understanding of quality systems (QMS) and quality documentation requirements.
• Practical knowledge of FDA regulations and ISO standards relevant to regulated manufacturing.
• Proficiency in root cause analysis and development of corrective and preventive action plans.
• Ability to work cross-functionally with Manufacturing, R&D, and Quality teams.
• Ability to manage multiple priorities and operate effectively in a fast-paced environment.
• Bachelor's degree preferred, ideally in engineering or life sciences.
• Experience with process validation or equipment qualification (IQ/OQ/PQ).
• Familiarity with risk management tools and methods such as FMEA and ISO-based risk frameworks.
• Exposure to medical device or pharmaceutical industry quality practices.
• Knowledge of supplier quality concepts and participation in audit activities.

Additional Skills & Qualifications

• Experience supporting process improvement initiatives or transitions of quality systems and workflows.
• Familiarity with Smart Solve or similar electronic Quality Management System (eQMS) tools.
• Audit experience, including participation in internal or external audits.
• Quality-related certifications…