Senior Quality Engineer

Quality Engineer

The Quality Engineer supports and leads quality operations within a regulated manufacturing environment, ensuring strict compliance with FDA and ISO standards. This role focuses heavily on CAPA ownership, non-conformance management, and day-to-day quality system execution, while also contributing to cross-functional projects, process validation, and ongoing process and system improvements.

Responsibilities:

• Lead CAPA investigations from initiation through root cause analysis, corrective and preventive action planning, implementation, effectiveness verification, and closure.
• Review, manage, and approve non-conformances and quality records, including equipment-related incidents, ensuring timely and compliant documentation.
• Support daily quality operations in a fast-paced manufacturing environment, providing real-time guidance to resolve quality issues on the production floor.
• Participate in and help facilitate quality review boards such as Material Review Board (MRB) and CAPA review meetings, preparing data and documentation for decision-making.
• Draft, review, and maintain validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV).
• Assist with process validation and equipment qualification activities, ensuring that protocols, reports, and supporting data meet regulatory and internal requirements.
• Support risk management activities, including participation in Failure Modes and Effects Analysis (FMEA) and alignment with applicable ISO standards.
• Coordinate cross-functional activities across Manufacturing, Research and Development (R&D), and Quality teams to drive issue resolution and continuous improvement.
• Support multiple small projects related to Quality Management System (QMS) improvements, process optimization, and system or workflow updates.
• Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for corrective and preventive actions and continuous improvement.
• Contribute to internal audits and compliance activities, supporting audit preparation, execution, and follow-up actions.
• Review and approve quality documentation and records to ensure accuracy, completeness, and alignment with regulatory and company standards.
• Coordinate meetings, track action items, follow up on commitments, and communicate status and risks across teams and stakeholders.
• Operate effectively in a fast-paced environment with shifting priorities, managing multiple tasks and projects simultaneously while maintaining high quality standards.
• Support ongoing quality and process improvement initiatives, including participation in system transitions and enhancements to QMS tools and workflows.

Essential

Skills:

• Quality engineering experience in a regulated manufacturing environment.
• Hands-on experience leading CAPA investigations, not only supporting them, including root cause analysis and corrective action planning.
• Experience managing, reviewing, and approving non-conformances and related quality records.
• Experience working in an FDA-regulated environment such as medical device, pharmaceutical, food and beverage, or aerospace.
• Manufacturing experience within a regulated environment, working closely with production teams.
• Strong understanding of Quality Management Systems (QMS) and quality documentation requirements.
• Proficiency with root cause analysis methods and corrective and preventive action planning.
• Ability to work cross-functionally with Manufacturing, R&D, and Quality teams and manage multiple priorities in a fast-paced setting.
• Exposure to validation activities, including IQ, OQ, and PQ.
• Familiarity with ISO standards relevant to quality systems and risk management.
• Bachelor's degree preferred in engineering or life sciences; an associate degree may be considered with the expectation of obtaining a degree for long-term conversion.

Additional Skills &

Qualifications:

• Experience with process validation and equipment qualification, including development and execution of IQ/OQ/PQ protocols and reports.
• Familiarity with risk management tools and methodologies, such as FMEA, in alignment with ISO requirements.
• Experience in medical device or pharmaceutical industries is strongly preferred.
• Exposure to supplier quality activities and supplier-related audits.
• Experience supporting process improvement initiatives or transitions between QMS tools or workflows.
• Knowledge of Smart Solve or similar electronic QMS platforms is a plus.
• Audit experience, including participation in internal or external audits.
• Quality-related certifications such as Certified Quality Engineer (CQE) or Six Sigma are preferred but not required.

Work Environment:

This is an onsite role with standard hours of 8:00 a.m. to 5:00 p.m., Monday through Friday. The position is primarily desk-based with a heavy focus on documentation, investigations, data analysis, and cross-functional coordination. The role also involves regular interaction with…