Description

Manage process validation, optimization, and regulatory compliance for medical device manufacturing.

This role is on-site.

Responsibilities

• Assess IQ, OQ, and PQ protocols and reports to ensure regulatory and procedural compliance.
• Conduct manufacturing process audits to identify documentation gaps and update Quality Management System (QMS) documents.
• Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM.
• Execute validation protocols, perform sample measurements, and generate comprehensive IQ, OQ, and PQ reports.
• Run statistical reports to analyze process capability, variability, and performance trends.

Required Skills

• 5+ years of experience in medical device manufacturing.
• Hands-on experience with CNC Machining and DCM.
• Strong understanding of FDA, ISO 13485, and GMP requirements.
• Proficiency in statistical analysis tools such as Minitab or JMP.
• Experience with QMS systems and documentation practices.
• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Strong analytical, problem-solving, and communication skills.

Key Skills

Education

Bachelor's or Master's degrees