Quality Engineer

Job Responsibilities:

• Track, analyze, and report key quality metrics; identify patterns or issues using statistical methods. Collaborate with cross-functional teams to investigate deviations, out-of-specification results, and customer complaints. Conduct root cause analyses and manage CAPA implementation. Plan and perform audits of quality systems and drive continuous improvement initiatives.
• Implement and maintain quality and technical specifications in coordination with internal stakeholders. Ensure customer product specifications align with operational capabilities and regulatory requirements. Maintain organized repositories of technical and quality documents for knowledge sharing.
• Support new projects with technical assistance, validation, and consultation to ensure process quality and product reliability. Define qualification and validation activities and prepare/review validation documents, including protocols and reports. Collaborate with Operations and Engineering to ensure timely execution of validation and qualification activities.
• Support development and manufacturing processes in compliance with applicable regulatory requirements (e.g., FDA, ISO 13485). Ensure policies and procedures meet regulatory and industry standards. Develop best practices and train quality staff in metrology, GD&T, statistical process control, and inspection techniques.
• Plan and oversee quality aspects of new development programs and design transfers. Execute projects related to product and process quality improvement, including the implementation of new inspection methods. Collaborate with Operations and Engineering on process and equipment qualifications.
• Participate in audits and inspections, providing required information, documentation, and explanations to internal and external stakeholders.

Qualifications:

• Bachelor of Science in a technical field (e.g., Engineering, Material Science, Data Analytics, Statistics) or equivalent work experience.
• 3–5 years of experience in Quality Assurance, Quality Engineering, or Process Engineering in manufacturing.
• Strong communication skills, including the ability to train staff and communicate quality standards effectively.
• Knowledge of regulatory standards such as ISO 9001, ISO 13485, and applicable FDA cGMPs.
• Proficient in geometric dimensioning and tolerancing