Job Description

Job Title:

QC Engineer - MedTech Electronics

Department:

Operations

Reports to:

Production Manager

Job Summary

The QC Engineer is responsible for ensuring the quality and compliance of electronic MedTech products throughout the product lifecycle. This role involves developing and implementing quality control plans, conducting inspections, and collaborating with cross-functional teams to maintain the highest product quality standards.

Key Responsibilities

Quality Planning:

Develop and implement comprehensive quality control plans for electronic MedTech products based on provided QC checkpoints (e.g., Acrylic products QC, 3D parts QC, circuit QC, final product QC).

Inspection and Testing:

Conduct incoming, in-process, and final product inspections and tests to ensure compliance with specifications and regulatory requirements.

Documentation:

Maintain detailed and accurate quality records, including inspection reports, test results, and non-conformance reports.

Process Improvement:

Identify and implement process improvements to enhance product quality and efficiency.

Regulatory Compliance:

Ensure adherence to all relevant regulatory standards, such as ISO 13485, FDA, and CE.

Root Cause Analysis:

Investigate product failures and defects, conduct root cause analysis, and implement corrective actions.

Calibration and Maintenance:

Oversee the calibration and maintenance of quality control equipment.

Supplier Quality:

Collaborate with procurement to ensure supplier quality and compliance.

Audit and Certification:

Participate in internal and external quality audits and certifications.

Qualifications

Bachelor's degree in Electrical Engineering, Electronics Engineering, or a related field. Minimum of [number] years of experience in quality control, preferably in the MedTech industry. Strong knowledge of quality management systems (ISO 13485). Proficiency in statistical process control (SPC) and other quality tools. Excellent problem-solving and analytical skills. Attention to detail and ability to work under pressure. Strong communication and interpersonal skills.
Job Type: Full-time

Pay: ?25,000.00 - ?37,500.00 per month

Experience:

* total work: 1 year (Preferred)