Quality Engineer

Position Overview

We are seeking a Quality Engineer to join our team and support quality management initiatives across manufacturing and operational processes. This role will be responsible for driving compliance, supporting continuous improvement efforts, and ensuring products and processes meet established quality standards. The ideal candidate will have experience in auditing, corrective and preventive actions, validation activities, and quality systems within a regulated environment.

Key Responsibilities

• Conduct supplier audits and support supplier quality improvement initiatives.
• Perform internal audits and assist with maintaining compliance to quality management system requirements.
• Lead and support Root Cause Analysis and Corrective and Preventive Action (CAPA) activities.
• Participate in Non-Conforming Material Review Boards (MRB) and support disposition of nonconforming materials.
• Investigate customer complaints and ensure timely resolution through effective corrective actions.
• Manage and support change control processes for both products and manufacturing processes.
• Plan, execute, and document product and process validation activities.
• Collaborate with cross-functional teams to identify quality risks and implement process improvements.
• Support continuous improvement initiatives through data analysis and problem-solving methodologies.
• Maintain quality records and documentation in accordance with company and regulatory requirements.

Qualifications

Required

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• Experience working within a quality engineering, quality assurance, or manufacturing quality environment.
• Knowledge of quality systems, auditing practices, CAPA processes, validation, and change control.
• Strong problem-solving and root cause analysis skills.
• Excellent communication and organizational abilities.
• Proficiency with Microsoft Office applications, particularly Excel.

Preferred

• ISO 13485 Lead Auditor experience.
• ISO 13485 Internal Auditor certification.
• Experience using Minitab for statistical analysis and process improvement.
• Experience with Oracle ERP systems.
• Experience working in a regulated manufacturing environment, including medical device or related industries.