Quality Engineer

About the Role

The Quality Engineer serves as a key quality and regulatory resource within an FDA-regulated manufacturing environment. This role partners closely with manufacturing, inspection, and customer-facing teams to ensure products consistently meet internal specifications, customer requirements, and applicable regulatory standards. The Quality Engineer leads continuous improvement initiatives, supports product and process lifecycle activities, and ensures compliance with FDA Quality System Regulations, sterilization standards, and cleanroom requirements.

Key Responsibilities

Quality Engineering & Continuous Improvement

Lead continuous improvement initiatives within assigned manufacturing areas using data-driven analysis.

Perform root cause analysis and implement corrective and preventive actions (CAPA) in alignment with FDA expectations.

Review, investigate, and disposition nonconforming product in accordance with established quality procedures.

Product & Process Lifecycle Management

Support the full product lifecycle from introduction through sustained production, including design transfer, process qualification, validation, and ongoing process monitoring.

Develop and maintain control plans, qualification protocols (IQ / OQ / PQ), and risk-based quality documentation to minimize scrap and prevent customer returns.

Ensure change management activities are properly evaluated, documented, and approved throughout the product lifecycle.

Regulatory Compliance, Sterilization & Cleanroom Oversight

Verify that manufacturing instructions, SOPs, and quality records comply with customer requirements and FDA regulations, including 21 CFR Part 820.

Support sterilization and cleanroom-controlled manufacturing processes in compliance with FDA and applicable ISO standards.

Ensure validation activities meet FDA expectations for special processes, including sterilization.

Cross-Functional Support & Training

Support quality inspectors and technicians by developing, maintaining, and explaining procedures, work instructions, and quality standards.

Partner with manufacturing, production, and customer service teams to resolve quality issues and maintain regulatory alignment.