Quality Assurance Engineer

As a Quality Assurance Engineer, you will serve as a critical link between production and regulatory compliance, ensuring that manufactured components meet rigorous industry standards. You will drive product integrity by leading process validations, managing non-conformance resolutions, and mentoring technical staff to foster a culture of continuous improvement.

• Oversee the lifecycle of product quality, from incoming material inspection to final release, ensuring full adherence to QMS and regulatory requirements.
• Lead root cause analysis and CAPA initiatives to address manufacturing deviations and customer complaints, effectively preventing recurrence.
• Collaborate with cross-functional engineering teams to refine Bills of Materials, assembly procedures, and technical drawings for optimal production outcomes.
• Design and implement robust test method validations and inspection protocols to verify product integrity against design specifications.
• Utilize statistical tools such as Cpk, DOE, and hypothesis testing to monitor process capability and drive data-backed operational improvements.
• Provide technical guidance and mentorship to quality technicians and inspectors to ensure consistent application of quality standards.
• Support external audits and regulatory inquiries by maintaining accurate, compliant Device History Records.

Required Skills

• Bachelor’s degree in Engineering or a related technical field.
• 2-5 years of professional experience in a quality engineering or manufacturing environment.
• Strong proficiency in Minitab and Microsoft Office suite for data analysis and reporting.
• Deep understanding of international quality standards such as ISO and QSR.
• Proven ability to manage complex projects independently while communicating effectively across departments.

Preferred Skills

• Professional certifications including CQE, CSQE, CRE, or CQA.
• Six Sigma Green Belt or Black Belt certification.
• Experience with product transfers and large-scale process validations.