Description

You will manage validation, testing, and process improvement for medical device production in Ponce, Puerto Rico.

This role is on-site.

Responsibilities

• Execute qualification, verification, and validation activities including IQ, OQ, MSA, and PQ.
• Perform root cause analysis (RCA), NCR, and CAPA responses to manage material disposition and process updates.
• Drive execution of validation and PFMEA activities while conducting site and factory acceptance tests.
• Apply statistical methods such as SPC, SQC, and DOE to analyze process models and recommend improvements.
• Design, develop, and validate equipment and processes to optimize production systems.

Required Skills

• 5+ years of experience in engineering roles.
• Proficiency in Quality Engineering, design, development, and testing.
• Experience with IQ, OQ, MSA, and PQ validation protocols.
• Ability to perform Root Cause Analysis (RCA), NCR, and CAPA documentation.
• Knowledge of PFMEA, SPC, SQC, and DOE statistical methods.
• Experience with DFM/DFA and process mapping.
• BS Degree in Mechanical Engineering or equivalent.

Preferred Skills

• Experience in packaging engineering, medical devices, or pharmaceutical industries.
• Broad knowledge of Mechanical and Manufacturing Engineering.

Key Skills

Education

BS Degree