Manufacturing Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

3d

About The Position

The Manufacturing Specialist works in Manufacturing Services within the Quality Systems area. The role provides manufacturing-floor and process support, maintains manufacturing procedures, supports process monitoring and new product introductions, and contributes to non-conformance and CAPA investigations and closure. The schedule is administrative and may vary according to business needs. The position requires English and Spanish bilingual proficiency, project management skills, and qualifying manufacturing operations experience.

Requirements

• Master’s degree and 2 years of Manufacturing Operations experience, or Bachelor’s degree and 4 years of Manufacturing Operations experience.
• Bilingual in English and Spanish.
• Project management skills.
• Experience providing on-the-floor support to assess process performance by observing floor operations and reviewing performance data.
• Experience participating in New Product Introductions (NPI), including assessing documentation, material, and training requirements.
• Experience assisting change owners with Change Control (CCRB) packages that impact the process.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure they reflect current operations and serve as a document owner.
• Assess process performance through observation of floor operations and review of performance data; evaluate, plan, and implement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and may provide training on scientific or technical aspects of the process.
• Support establishment of process-monitoring parameters and control limits; collect process-monitoring data and support assessment of deviations.
• Support timely execution of process-monitoring quarterly reports.
• Ensure non-conformances are triaged within the established goal.
• Author investigation reports.
• Execute corrective actions.
• Manage non-conformance and CAPA closure within the established goal.
• Monitor and communicate incident trends.
• Review equipment/system root cause analysis investigations and support trend evaluations.
• Participate in new product introductions, including assessing documentation, material, and training requirements.
• Assist change owners with Change Control Review Board (CCRB) packages that impact the process.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level