Eric Ruiz

Support and lead regulatory projects on which roles and responsibilities included the following:

• Translate project Timelines and business priorities to strategic planning phases plan, Master Regulatory Schedule, driving projects execution to completion.
• Ensured compliance with Strategic Planning governance, processes, procedures, metrics, standard times and efficiencies.
• Assess LATAM countries Dossiers to determine regulatory impact.
• Lead change assessment team on reviews for 119 countries assessment response regarding its resulting Regulatory Action.
• Analyze, summarize and prepare impact reports to present Project Leads the impact of the proposed change and provided alternatives of strategies to perform.
• SME on country requirements needed to fulfill the regulatory action reported.
• Determine regulatory impact and strategy to address the submission to country.
• Monitor country change assessment timeline to maintain metrics and efficiency of process.
• Leaded Kaizen event to improve Assessment templates and contribute with additional efficiency cutting time in the creation of country assessment templates.
• Communicated with countries representatives in a daily basis to clarify project doubts, templates response doubts and process doubts.
• Cost associated to regulatory impact and resources (overall project cost).
• Logistics of selling new product vs old product (forecast).

Strong Results achieved with a cost reduction of 3 million on the project first year.

Sterilization Assurance Specialist:

Support Sterility Assurance Department in all activities related to sterilization such as: validations, reports, adoptions and audits. Review validations protocols for sterilization processes. Ensure the compliance with regulatory standards requirements (FDA, ISO, EU, and GLP guidelines), procedures and specifications. Provide support on Internal and external Audits such as TUV and FDA.

Lead and support activities as Subject Matter Expert (SME) for sterilization processes (EO and GAMMA), such as but not limited to:

• Sterilization process analysis and sterilization reports
• Advice new products introduction team with sterilization assessment
• Selection of sterilization Master Products
• Root cause analysis investigation for sterility related non conformances for current manufacture and new products.
• Dummies generation for sterilization validations assuring density and configuration of worst case scenario
• Support generation for Sterilization Assurance department budget.
• Leaded and performed gamma test method change for high volume products resulting in annual reduction costs for $175K.
• Coordinate and perform annual re-qualification and related testing for:
  

EO Sterilization chambers

Gamma sterilization (Cobalt 60)

ECA: Instruments, Endoscopy and PPU

• Monitor and report Sterility Assurance metrics to the Quality Review Board. This includes report data results on operational performance to ensure compliance on company quality goals.
• Assess results in terms of acceptability to sterilization assurance manners supporting quality operational manufacturing process.
• Lead environmental controls programs for controlled environmental manufacturing rooms ISO class 8.
• Support the monthly and quarterly programs for bio burden and sterility controls for product families.
• Perform periodic auditing for contract sterilization suppliers.
• Review and approve sterilization validation protocols and reports.
• Member of Change Control Board (CCB) to assess during design changes, supplier changes and others that could impact the product current sterilization validated state.

Responsibilities as Quality Engineer (QE) - Injection Molding Area & Irrigation Business Units:

• Investigate non conformances to implement corrective and preventive actions to prevent reoccurrence.
• Perform internal and external audits as required. Interact with suppliers to standardize inspection methods and resolve quality issues.
• Supported complaint investigations.
• Perform molding validations, review and approve reports such but not limited to IQ, OQ-E, Manufacturing Technical Reports and Engineering Samples.
• Implement engineering changes, engineering orders and temporary changes.
• Reviewed, changed and created manufacturing technical instructions, attribute charts and masters cycles for the Injection Molding process.
• Investigate non-conformances related to molded components.
• Manage non-conformances and reprocesses at the manufacturing area in order to ship product and avoid backorder.
• Reviewed Engineering Change Orders (ECOs), Process Procedure Maps (PPMs) and technical reports as required.
• Provided quality awareness to operators to maintain and reinforce Good Manufacturing Practices (GMPs) at the manufacturing areas as per current site procedures and regulations.
  

• Work on re-qualification of environmental controlled areas (ECAs). Performed qualification protocols and reports.
• Executed re-qualification assessment for sterilization ETO chambers located at Steritech facilities at Salinas Puerto Rico.
• Investigated, documented and provided root causes and corrective actions for non-conformances regarding Gamma sterilization process. Responsible of product disposition after reprocess or investigation.
• Reduced Sterilization doses for Wire Caddy product resulting in cost reduction of $200K and leading into Doses Reduction program for product under Bioburden Control.
• Designed new microbiology laboratory facilities for SPR (layout schematic creation and development).
• Support Quality Assurance Team on non-conformances and engineering changes documentation as required.
• Conduct investigations with suppliers in order to avoid non conformances. Supported creation of new laboratory facilities on site by developing schematics and design.
  

• Work in lens injection molding process as Product Support associates in charge of machine change over, set up and calibration process. Supports production team to ensure comply with requirements of customer and regulations.
  

• Lead projects related to electrical system design to increase energy efficiency of government facilities.
• Designed system plots and simulation, cost analysis and design specifications assuring compliance of electrical regulations.
  

• Supervise crew in wiring process and implementation of substation and electrical transformers. Using Project Management and problem solving tools achieved completion of project tasks on target as per project schedule.
• Leveraged strong supervisory and problem-solving skills to support installation team in successfully implementing electrical system on Gautier Benitez Street in Caguas.
• Support Field Engineer to complete Megger Test and installation approval processes.
• Assist Project Engineer in resources coordination to complete tasks according with project schedule.
  

• Lead electrical system design for Home Elderly facility, including electrical distribution for each apartment, common areas, parking and substation design.
• Designed Illumination system for parking and common areas and supported substation design process.
• Developed project schedule and cost analysis per square feet and by raw materials and resources for Electrical System Design.