Summary

The Senior / Quality Engineer (QE) provides guidance, expertise, and services to ensure process and product quality of instrument products. The QE supports compliance to the ISO 9001 quality system; internal auditing; material, process, and production controls; and other aspects of quality assurance to ensure compliance to standards, regulations, and guidelines. The QE works cross-functionally with R&D to support new product introduction; with Manufacturing to create and modify procedures to ensure requirements are met; with Procurement to ensure incoming material meets specifications and suppliers meet quality standards; and within Quality to ensure overall compliance of products and processes.

Key Accountabilities

• Demonstrate knowledge of and adherence to site safety requirements.
• Execute goals and strategy for corporate and site level activities based upon company's business objectives.
• Support supplier quality management activities, including audits and supplier performance evaluations.
• Investigate customer complaints and internal non-conformances, leading root cause analysis and implementing corrective and preventive actions.
• Participate in new product development projects, providing input on design for manufacturability and quality.
• Collaborate with various teams and leadership to develop and implement quality assurance strategies, policies, and procedures.
• Conduct regular inspections and tests on products, materials, equipment and processes to ensure compliance with quality standards and regulations.
• Analyze quality data and metrics to identify trends, root causes of issues, and opportunities for improvement.
• Develop and maintain quality documentation, including standard operating procedures, work instructions, and quality records.
• Lead or participate in cross-functional teams to address quality-related issues and drive continuous improvement initiatives.
• Maintain accurate records and reports related to quality control and compliance activities.
• Perform other duties necessary for the effective operation of the QMS.

Requirements

• Bachelor's degree in engineering or related field
• 3 years of relevant working experience in a customer quality, process quality or engineering role, preferably in a manufacturing environment.
• Experience with root cause analysis, corrective actions, and quality improvement methodologies (e.g., Six Sigma, Lean).
• Ability to support Quality Management during audits and inspections.
• Excellent analytical and problem-solving skills, with the ability to interpret technical data and drawings.
• Knowledge of computer software like SAP, Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to prioritize and work independently and proactively is critical for success.
• Previous experience in an ISO 9001, 13485 or GMP compliant manufacturing environment
• Previous experience with quality management system software for quality data tracking and document change management (e.g., TrackWise, MasterControl, Agile, QCBD, etc.) and internal auditor certification.