Quality Assurance Engineer

About the Role

This role supports quality assurance, quality control, and continuous improvement initiatives to ensure products and manufacturing processes meet applicable regulatory and quality standards.

Position Summary

The Quality Assurance Engineer will collaborate with Operations, Engineering, suppliers, and cross-functional teams to investigate quality issues, manage corrective and preventive actions, and improve manufacturing processes. This role is ideal for an early-career quality professional looking to build experience in a regulated manufacturing environment.

Key Responsibilities

• Partner with Operations and cross-functional teams to maintain product and process quality.
• Manage internal and supplier nonconformances, investigations, and timely resolution.
• Support Corrective and Preventive Actions (CAPAs), root cause analysis, and Supplier Corrective Action Requests (SCARs).
• Support Material Review Board (MRB) activities and disposition of nonconforming products.
• Review and support change management activities for suppliers, products, and manufacturing processes.
• Develop, review, and update quality procedures and documentation.
• Monitor quality KPIs, analyze trends, and implement corrective actions.
• Support manufacturing complaints, product field actions, product holds, and containment plans.
• Apply statistical methods to process analysis and quality control.
• Support internal and external audits, process validation, equipment qualification, and Measurement System Analysis (MSA).
• Perform quality activities related to engineering changes, supplier changes, and manufacturing transfers.
• Support risk management, Lean initiatives, standardization, and waste reduction.
• Apply Human Error Prevention principles within the manufacturing environment.
• Maintain supplier relationships, monitor performance, and help ensure the delivery of quality materials and services.

Qualifications

• Bachelor’s degree required.
• 0–2 years of experience in Quality Assurance, Quality Engineering, or Regulatory Affairs; regulated industry experience preferred.
• Familiarity with ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Understanding of quality and engineering principles, including CAPA, risk management, audits, and statistical methods.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong analytical, problem-solving, written, and verbal communication skills.
• High attention to detail and the ability to manage multiple priorities in a fast-paced environment.
• Strong interpersonal skills with the ability to collaborate effectively across teams and build trusted relationships.
• Self-motivated, adaptable, and committed to continuous improvement.
• Comfortable representing Quality in cross-functional discussions and working with teams across multiple sites.
• Willingness to travel as needed.

Preferred: Knowledge of risk-based thinking, statistical concepts, and quality improvement methodologies.