CMM Programmer

Description

• Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820) and other international standards.
• Work closely with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to ensure product quality throughout the development process.
• Maintain thorough and accurate records of all testing procedures, results, and corrective actions to comply with regulatory audit requirements.
• Assist in internal and external audits by regulatory bodies, ensuring all processes meet the necessary compliance standards.
• Create and review detailed test protocols that include objectives, methods, acceptance criteria, and statistical methods.
• Execute test protocols, including software validation, biocompatibility testing, electrical safety testing, and sterilization validation, depending on the device, component, or assembly.
• Conduct root cause analysis for non-conformances and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
• Perform Failure Modes and Effects Analysis (FMEA) to systematically evaluate and document potential failure points and their impact on patient safety.
• Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.
• Conduct risk assessments to identify potential hazards associated with the medical device and develop mitigation strategies.
• Provide training to team members and other departments on quality standards, testing procedures, and regulatory compliance.
• Identify and document non-conformances in product quality or processes.

Requirements

• Six Sigma Certifications
• 3+ years' experience in validation or quality in a regulated industry.
• Certified Quality Engineer (CQE)
• CMM programming
• Knowledge of FDA and 21 CFR Part 820 standards.
• CMM programming - Pc-Dmis.
• Root cause analysis
• Medical device expertise
• PC-Dmis programming
• Statistical analysis
• Lead Auditor certification
• Bachelor’s degree in Engineering, Life Sciences, or related field.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance