Quality Engineer - Judge Group

We are seeking a highly skilled and motivated Quality Engineer. The ideal candidate will have extensive experience in medical device manufacturing and be proficient in GD&T (Geometric Dimensioning and Tolerancing) and CMM (Coordinate Measuring Machine) operations. This is a hands-on role that requires working on the plant floor to ensure the highest quality standards are met.

Key Responsibilities:

• Develop, implement, and maintain quality assurance protocols and procedures for medical device manufacturing.
• Perform inspections and tests using GD&T and CMM to ensure products meet specifications and regulatory requirements.
• Collaborate with cross-functional teams, including engineering, production, and regulatory affairs, to address quality issues and implement corrective actions.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) to resolve quality issues.
• Monitor and analyze quality data to identify trends and areas for improvement.
• Train and mentor production staff on quality standards and best practices.
• Participate in internal and external audits to ensure compliance with industry standards and regulations.
• Maintain accurate documentation of quality control processes, inspections, and test results.

Qualifications:

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• Minimum of 3-5 years of experience in quality engineering within the medical device manufacturing industry.
• Proficiency in GD&T and CMM operations.
• Strong understanding of regulatory requirements and quality standards for medical devices (e.g., ISO 13485, FDA regulations).
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Hands-on experience working on the plant floor and collaborating with production staff.