Summary
The Quality Assurance Engineer (QAE) provides guidance, expertise, and services to ensure process and product quality of instrument products. The QAE 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 QAE 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.
