Position Overview

The QA/QC Expert will ensure product and process quality through effective implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 9001:2015, relevant regulatory standards (e.g., cGMP), and internal policies. This role partners closely with manufacturing, R&D, suppliers, and external auditors to uphold high levels of quality and compliance.

Key Responsibilities

• Maintain and enhance the QMS to ensure compliance with ISO 9001:2015 and regulatory requirements.
• Plan, execute, and follow up on internal and external audits, including ISO 19011-based internal audits.
• Develop and oversee quality documentation—SOPs, protocols, reports, risk assessments (e.g., FMEA), CAPAs, nonconformance investigations.
• Collaborate with manufacturing engineers on process validation, control, software validation, and training. 
• Analyze quality data and metrics, generate insights and drive corrective/preventative actions.
• Lead supplier quality and inspections, facilitate root-cause analysis, and manage supplier CAPAs.
• Support equipment qualification, calibration/timeline management, and environmental monitoring—aligned with cGMP expectations.
• Serve as quality liaison during customer and regulatory audits; manage complaint handling and quality issue resolution.
• Promote continuous improvement initiatives and a culture of quality across the organization.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• 5+ years of experience in quality assurance/control roles within biotech, medical device, or pharmaceutical manufacturing.
• Expertise in ISO 9001:2015 implementation, maintenance, and internal auditing (ISO 19011).
• Thorough understanding of QMS, risk management (FMEA), CAPA, and change control methodologies.
• Experience with process and software validation, equipment qualification, calibration, and environmental monitoring.
• Strong analytical abilities—statistical analysis of quality metrics and data interpretation.
• Excellent communication and cross-functional collaboration skills.
• Demonstrated ability to manage customer and regulatory audits.
• Preferred: experience in cGMP and FDA-regulated environments.

Desired Attributes

• Certified Quality Auditor (CQA) or Quality Engineer (CQE).
• Certification or formal training in ISO 9001:2015, ISO 19011.
• Six Sigma or Lean certification.
• Experience working in global or matrixed organizations.
• Proficient with QMS and data analysis software/tools.