Job Summary
Quality Engineer II to ensure that products, manufacturing processes, and quality records comply with established quality standards and regulatory requirements. The ideal candidate will have experience in quality assurance or quality engineering, nonconformance investigations, CAPA, complaint management, and root-cause analysis.
Key Responsibilities
- Ensure compliance with FDA regulations, GMP, ISO standards, company policies, and applicable quality requirements.
- Implement, maintain, and improve the effectiveness of the Quality Management System (QMS).
- Identify quality risks and assess compliance with internal and external regulatory requirements.
- Conduct nonconformance investigations, CAPA activities, and product complaint investigations.
- Perform root-cause analysis and recommend corrective and preventive actions.
- Develop and maintain quality assurance procedures, forms, documentation, and systems.
- Analyze quality data, track trends, and identify manufacturing-related complaints.
- Prepare investigation reports and communicate findings to Quality Engineering, Regulatory Affairs, and other business partners.
- Lead meetings and communicate quality system updates, concerns, and improvement opportunities.
- Collaborate with cross-functional teams, customers, contractors, and vendors to resolve quality issues.
- Support continuous improvement initiatives and maintain accurate quality records.
Required Qualifications
- Bachelor's degree in Engineering, a technical field, or equivalent experience.
- 2–5 years of technical experience.
- Previous experience in Quality Assurance or Quality Engineering.
- Knowledge of quality tools, methodologies, and root-cause analysis.
- Experience with nonconformance investigations, CAPA, or complaint management.
- Strong computer skills, including statistical/data analysis and report writing.
- Excellent verbal and written communication skills.
- Strong organizational, problem-solving, and follow-up skills.
- Ability to manage multiple priorities and work independently or collaboratively in a dynamic environment.
Preferred Qualifications
- Detailed knowledge of FDA regulations, GMP, and ISO 13485.
- ASQ Certified Quality Technician (CQT), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA)
- Six Sigma training and experience in root-cause analysis and problem-solving
- Experience in medical-device manufacturing or a regulated manufacturing environment.