Quality Engineer - NN King Of fruit CO., LTD.

About the Role 

Meticuly, a pioneering deeptech MedTech startup, is transforming cranio-maxillofacial surgery through patient-specific titanium implants. As a Quality Engineer, you will not just be sitting at a desk doing paperwork; you will be on the ground, actively making decisions and ensuring the highest product quality.

Reporting directly to the QC Manager, you will oversee incoming materials, coordinate with product designers, manage outsourced calibration, and handle our Quality Management System (QMS). You will be a key problem-solver, leading post-market surveillance (PMS) and ensuring our life-changing implants comply with global medical standards.

 Key Responsibilities (What you will actually do):

• QC Operations & Decision Making: Conduct Incoming Material inspections and monitor the production QC process. You will be the key decision-maker when quality issues arise and will actively coordinate with relevant teams to resolve them on the spot.

• Product Transfer Collaboration: Work closely and communicate directly with Product Designers during the Product Transfer phase to ensure new designs meet manufacturing and quality standards.

• Calibration Management: Manage and oversee the calibration of organizational machines and tools by coordinating directly with outsourced calibration service providers.

• Post-Market Surveillance (PMS) Leadership: Track post-usage performance. If user feedback or defects occur, you will gather and lead a cross-functional team to troubleshoot, find the root cause, and implement solutions.

• QMS & Audit Compliance (ISO 13485): Manage QMS documentation specifically for the QC team. Act as the team representative during both Internal and External Audits (ensuring we are always audit-ready without getting bogged down in endless paperwork).

• MSA & Non-Conforming Management: Maintain the Measurement System Analysis (MSA) and lead CPAR activities for any non-conforming products to ensure effective closure.

Qualifications

• BEng in Materials, Mechanical, Industrial Engineering, or a relevant field.

• 1-2 years of direct experience in Quality Control (QC/QA), preferably in a manufacturing or medical device environment (Ready to hit the ground running).

• Thorough knowledge of QC 7 tools and practical problem-solving skills.

• Understanding of ISO 13485 and MDSAP requirements.

• Certificate of calibration system (is a plus).

• Strong communication and coordination skills (must be able to talk to designers, production teams, and external suppliers effectively).

• About Meticuly
• Established in 2017, we provide doctors with personalized bone implants that are designed from individual patient CT scans.
• The goal of any surgeon is to complete surgeries with the best clinical outcomes in the shortest amount of time. Meticuly works for doctors who operate on medical implants to achieve this goal with our advanced AI-assisted software, high quality manufacturing, and efficient workflow. For doctors, we redefine and improve the bone surgery process to enhance patients’ personalized care. For patients, we produce a reliable yet affordable alternative solution.