Role: Quality Engineer

Location: Ponce, Puerto Rico

Job Description:

• Contribute to continuous improvements in product cost and quality.
• Participate in DFM/DFA activities, ensuring packaging and production processes are considered.
• Collaborate with Quality Engineering to provide manufacturing support.
• Create standardized work instructions and process maps for optimized production systems and value streams.
• Support line validation/qualification activities, including IQ, OQ, MSA, and PQ.
• Perform Root Cause Analysis (RCA), NCR, and CAPA resolutions.
• Conduct qualification, verification, and validation activities for medical device production.
• Collaborate with cross-functional teams to troubleshoot production issues.
• Design, develop, test, and validate equipment and processes; analyze process models and recommend improvements.
• Execute validation and PFMEA activities per project plans.
• Apply statistical and analytical methods such as SPC, SQC, and DOE.
• Contribute to the Capital Expense Request (CER) process, specifying costs for packaging, labeling, and sealing equipment aligned with product standards and capacity demands.
• Provide engineering analysis and documentation for material disposition, process updates, NCRs, and CAPA.
• Conduct Site Acceptance Tests (SAT) and Factory Acceptance Tests (FAT) based on North Haven standards.
• Perform validation gap analysis for various product families.
• Plan and initiate CDPs associated with validation activities.
• Coordinate with stakeholders to ensure seamless execution of tasks.

Qualifications:

• BS Degree in Mechanical Engineering or equivalent; MS Engineering preferred.
• Minimum of 3 years of applicable experience in packaging engineering, medical devices, pharmaceuticals, or related industries.
• Broad knowledge of Mechanical/Manufacturing Engineering principles.