Quality Assurance Specialist

We are seeking a detail-oriented Quality Assurance Specialist to ensure products, processes, and services consistently meet established quality standards and customer expectations. The ideal candidate will play a critical role in maintaining quality systems, conducting audits, identifying process improvements, and driving compliance across operations. This role requires strong analytical skills, attention to detail, and a proactive approach to quality management.

Key Responsibilities

• Develop, implement, and maintain quality assurance processes, standards, and procedures.
• Monitor product and process quality through inspections, audits, and testing activities.
• Conduct root cause analysis and drive corrective and preventive actions (CAPA) for quality issues.
• Investigate customer complaints, non-conformances, and quality incidents to identify improvement opportunities.
• Collaborate with cross-functional teams to ensure quality requirements are integrated into operational processes.
• Review and maintain quality documentation, SOPs, records, and compliance reports.
• Analyze quality metrics and prepare reports for management review.
• Support internal, external, customer, and regulatory audits.
• Identify risks and recommend process improvements to enhance efficiency and quality performance.
• Ensure compliance with applicable industry standards, regulatory requirements, and company policies.

Required Qualifications

• Bachelor's degree in Engineering, Quality Management, Life Sciences, Manufacturing, or a related field.
• 3+ years of experience in Quality Assurance, Quality Control, Compliance, or related functions.
• Strong understanding of quality management systems and quality assurance methodologies.
• Experience conducting audits, inspections, and quality reviews.
• Knowledge of root cause analysis techniques and corrective action processes.
• Familiarity with quality standards such as ISO 9001, ISO 13485, AS9100, GMP, or industry-specific regulations.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office and quality reporting tools.
• Excellent documentation and communication skills.

Preferred Qualifications

• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Green Belt, or equivalent.
• Experience working in manufacturing, healthcare, pharmaceuticals, medical devices, aerospace, automotive, technology, or related industries.
• Knowledge of statistical process control (SPC) and quality improvement methodologies.
• Experience with supplier quality management and vendor audits.
• Familiarity with risk management and regulatory compliance frameworks.