Quality Engineer/ QA Manager

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process.

Responsibilities

• Collaborate with R&D, QC, Operations, Sales & Marketing, and Manufacturing departments
• Ensure the supply of company products in accordance with company plans
• Support the VP of QA/RA in department activities, including setting annual goals and objectives, identifying areas for improvement, and implementing quality systems in line with Nanomedic’s quality policy and regulatory requirements
• Oversee the release of final products
• Conduct supplier and internal audits
• Monitor company validation activities
• Manage ECOs, CAPAs, MRBs, and complaints
• Prepare for external audits
• Assist in regulatory affairs activities

Qualifications

• Bachelor's degree or higher
• At least 5 years of experience as Quality Engineer or QA Manager in the medical device industry (Class IIa and above)
• Proven experience with implementation and maintenance of ISO 13485:2016 Quality Management Systems
• Familiarity with EU regulatory requirements (MDD/MDR); experience with US FDA regulations is an advantage
• Certified Quality Auditor (Lead Auditor certification is an advantage)
• Experience with quality and QC processes in a cleanroom environment