Quality Assurance Engineer

Job Overview

We are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our dynamic manufacturing team. In this role, you will be instrumental in ensuring that our products meet the highest quality standards by implementing rigorous quality systems, conducting comprehensive audits, and maintaining compliance with industry regulations. Your expertise will help drive continuous improvement initiatives, uphold regulatory and legal standards, and foster a culture of excellence across all production processes. This position offers an exciting opportunity to influence product quality at every stage of manufacturing, ensuring customer satisfaction and operational efficiency.

Responsibilities

• Oversee ISO 13485 quality management systems and certification effectiveness.
• Manage measurement accuracy and reliability.
• Monitor all internal quality performance issues of medical products and drive for improvement actions.
• Ensure products consistently meet customer specifications and internal standards.
• Collaborate across departments to meet corporate and quality objectives.
• Quality Planning & Documentation: Create standard operating procedures (SOPs), inspection criteria, and quality manuals.
• Process Control & Monitoring: Use Statistical Process Control (SPC) and data analysis to track production performance and catch variations early.
• Root Cause Analysis & Corrective Action: Lead investigations when defects happen, implementing corrective and preventive actions (CAPA).
• Audits & Compliance: Manage and verify compliance through internal and external audits.
• Supplier Quality Management: Collaborate with procurement teams to evaluate raw materials and monitor vendor performance.
• Any other duties assigned by the Management.

Requirements

• Diploma in Engineering or Science or equivalent relevant experience.
• Preferably trained and have good knowledge in Quality Control tools.
• Ability to work independently and in a team in a fast-paced environment with emphasis on accuracy and timeliness.
• Possess good and effective communication skills with all levels within the organization and suppliers.

Join us to be part of a forward-thinking organization committed to excellence in manufacturing!

Expected hours: 40.0 per week

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Work Location: In person