Senior Quality Engineer

Summary

The Senior Quality Engineer supports organizational quality initiatives by promoting adherence to quality system requirements and driving continuous improvement across teams. The role ensures that customer, internal, and regulatory expectations are met by contributing to effective quality processes, resolving quality issues, and maintaining accurate and compliant documentation.

This role applies scientific, risk‑based, and structured problem‑solving methods to identify, analyze, and resolve quality challenges such as nonconformances, material issues, or customer concerns. The engineer maintains key quality documentation, assists with risk assessments, and provides technical guidance to cross‑functional partners.

The position also supports validation, data analysis, and statistical techniques, while offering subject‑matter expertise during audits or process reviews.

Responsibilities

Responsibilities include, but are not limited to:

• Support implementation and maintenance of quality system requirements across applicable functions.
• Ensure work is completed accurately, on time, and in alignment with established quality expectations.
• Maintain quality documentation, risk assessments, and other required records.
• Conduct or support investigations into issues such as nonconformances, complaints, or deviations, and help drive corrective and preventive actions.
• Perform or assist with root‑cause analysis using structured problem‑solving tools.
• Support or lead updates to process controls, inspection methods, sampling plans, and related documentation.
• Assist with or execute validation activities including test method validation, equipment qualification, and process evaluation.
• Communicate with internal teams and external partners regarding quality‑related questions, product issues, and documentation changes.
• Assist with continuous improvement activities and support initiatives based on Lean or similar methodologies.
• Maintain and update risk assessment documentation for new and modified processes.
• Provide quality expertise related to change management, calibration, environmental controls, equipment maintenance, and other quality‑related processes.
• Participate in internal or external audits when technical or quality expertise is required.
• Perform additional duties or project work as assigned.

Training, Education, and Experience

• Bachelor's degree in engineering, science, or a related technical field.
• Several years of experience in quality engineering or a similar technical role.
• Familiarity with statistical methods, data analysis, and quality planning tools.
• Strong communication skills with the ability to interface with internal teams and customers.
• Experience with validation principles, documentation practices, and technical reporting.
• Working knowledge of process improvement methods; relevant certifications are beneficial.
• Ability to interpret and create technical drawings, procedures, and testing documents.
• Highly organized, adaptable, and capable of managing multiple priorities.
• Proficiency with standard office software and comfort working with data systems or ERP tools.

Competencies and Personal Attributes

• Strong analytical abilities and attention to detail.
• Clear, confident communicator with strong interpersonal skills.
• Independent, self‑driven, and accountable.
• Effective at identifying issues, analyzing information, and proposing solutions.
• Comfortable presenting technical information to diverse audiences.
• Organized and capable of handling multiple tasks simultaneously.
• Ability to work in both office and technical environments.