Quality Technician

Job Overview

We are seeking a Quality Technician to join a prominent medical device manufacturer operating in a highly regulated setting. This role is ideal for an experienced quality professional tasked with supporting rigorous quality assurance processes to guarantee products align with top-tier quality and regulatory standards.

Responsibilities

• Conduct inspections for incoming, in-process, and final products adhering to authorized procedures and specifications.
• Ensure adherence to current Good Manufacturing Practice (cGMP), quality benchmarks, and regulatory directives.
• Assist quality assurance teams, including Incoming Quality Assurance (IQA), Quality Control (QC), and metrology-related operations as needed.
• Accurately prepare quality documentation to maintain compliance and readiness for audits.
• Review and create batch manufacturing documentation to support production.
• Make informed decisions regarding the acceptance or rejection of incoming materials based on quality guidelines.
• Report quality deviations, issues, or non-conformances to designated personnel promptly.
• Contribute to change control processes by reviewing and updating relevant documents.
• Participate actively in internal audits and efforts to ensure compliance with the quality management system.
• Produce quality performance metrics and reports for management evaluation.
• Fulfill all required training to maintain compliance.
• Engage in initiatives aimed at continuous quality, safety, and operational improvement.
• Collaborate effectively with various departments to uphold operational excellence.

Required Qualifications and Experience

• Prior experience within a GMP-regulated manufacturing environment.
• Comprehensive knowledge of quality management systems and documentation standards.
• Meticulous attention to detail with a strong focus on accuracy.
• Competency in following standard operating procedures and regulatory requirements strictly.
• Strong organizational, communication, and analytical problem-solving abilities.
• Capability to work both independently and cooperatively within a team setting.

Preferred Credentials

• Higher education degree in Science, Engineering, Quality, or related disciplines.
• Experience in the medical device, pharmaceutical, or combination product sectors.
• Familiarity with ISO 13485 standards, FDA regulations, and cGMP compliance.
• Hands-on experience with incoming inspection, product release testing, batch record review, change control, and internal audits.
• Understanding of metrology techniques and processes.

Additional Information

For further discussion, candidates may contact the recruitment representative confidentially. By applying, you consent to your personal data being processed for recruitment purposes by the hiring company.