Quality Engineer

Quality Engineer (Contract)

This short-term Quality Engineer contract role (approximately six months) focuses on providing critical Quality Assurance support by clearing a backlog of investigations and contributing to key QA activities in a regulated environment. You will lead and support investigations related to nonconformances, CAPAs, and complaints, while also assisting with document control, batch release, and document reviews to ensure a full and varied workload throughout the contract.

The position requires strong experience in medical devices or similarly regulated industries, excellent root cause analysis capabilities, and clear, precise technical writing skills.

• Lead and support investigations for nonconformances (NC), CAPAs, and complaints to address a backlog of quality issues in a timely and compliant manner.
• Perform thorough root cause analysis using structured problem-solving methods to identify underlying causes of quality issues and recommend effective corrective and preventive actions.
• Document investigations clearly and accurately, producing high-quality technical reports that meet regulatory and internal quality standards.
• Support additional Quality Assurance activities such as document control, ensuring controlled documents are current, accurate, and properly maintained within the QMS.
• Participate in batch release activities by reviewing relevant documentation for completeness, accuracy, and compliance with applicable standards and procedures.
• Conduct detailed document reviews of procedures, technical documentation, and records to verify compliance with internal quality requirements and regulatory expectations.
• Collaborate closely with the Quality Assurance team and cross-functional partners, including R&D, service, and operations, to gather information and ensure alignment on investigation findings and actions.
• Review and interpret quality system procedures, technical documents, and regulatory requirements to support robust and compliant investigation practices.
• Utilize the QMS system (Qdocs) to manage investigations, documentation, and quality records in an organized and traceable manner.
• Contribute to continuous improvement initiatives within the quality system by identifying trends, recommending process improvements, and supporting implementation of enhanced QA practices.

• At least 5 years of experience working as a Quality Engineer or QA professional, with a strong focus on investigations.
• Proven experience conducting investigations involving nonconformances (NC), CAPAs, and complaints in a regulated environment.
• Strong understanding of general root cause analysis methodologies and their application to quality issues.
• Excellent technical writing skills, with the ability to produce clear, concise, and well-structured investigation reports and quality documentation.
• Experience working within a Quality Management System (QMS), including use of electronic systems such as Qdocs or similar platforms.
• Background in medical devices is preferred, or substantial experience in a regulated industry such as pharmaceuticals, biotechnology, or other FDA-regulated sectors.
• Knowledge of FDA regulations and expectations related to quality systems, investigations, and CAPA processes.
• Familiarity with ISO standards relevant to quality and medical devices (such as ISO-based QMS frameworks).
• Experience with quality control practices and principles in a regulated environment.

• Experience in a medical device environment, including understanding of device lifecycle, risk management, and post-market quality activities.
• Exposure to ISO-based quality standards and their application in daily QA activities.
• Comfort working with cross-functional teams including R&D, service, and operations to gather data and implement corrective and preventive actions.
• Ability to quickly learn and adapt to site-specific QMS tools, including Qdocs, and local procedures.
• Strong attention to detail and organizational skills to manage multiple investigations and documentation tasks simultaneously.
• Effective communication skills, both written and verbal, to present findings and collaborate with stakeholders at different levels.
• Demonstrated ability to work independently while also contributing as a proactive member of a small quality team.

You will work as part of a small, collaborative quality team of approximately three other professionals in a hybrid work setting. During the initial phase of the contract, you will spend the majority of your time onsite to receive hands-on training, become familiar with the quality system, and integrate with cross-functional partners. After this training period, a hybrid arrangement with approximately two days in the office each week may be suitable, depending on project needs and performance.

The environment is structured and regulated, with a strong emphasis on compliance, documentation accuracy, and adherence to FDA and ISO-based quality…