SUMMARY

• Analytical Engineer with more than 8 years of comprehensive experience in spearheading complex and effective technical projects within Medical Devices manufacturing industry.
• Possesses strong expertise in defining Testing Strategies, Data & Requirement Analysis, as well as verifying and validating devices according to Quality Assurance standards in all phases of Product Development Life Cycle.
• Demonstrate ability to catalyze lucrative results while complying with budget and time constraints.
• Seek to benefit top organization by recommending corrective actions on products, and delivering innovative medical solutions.
• Exhibit excellent communication skills; build high performing teams to inaugurate efficiency and productivity.
• An expert strategist with keen business acumen and a solid background in managing all aspects of a busy office.
• 8+ years' extensive experience in high - volume and fast-paced environment.
• Effective team player who enjoys performing all assigned duties independently.

AREAS OF EXPERTISE

• Environmental & Functionality Testing
• Statistical & Technical Writing
• Team Building & Leadership
• Quality Management System
• Corrective Actions & Recommendations
• Research & Analysis
• Quality Assurance
• Product Launch & Improvement
• Product Shelf-Life
• Product Development Lifecycle
• Test Strategies & Requirements
• Safety & Compliance
• Problem- Solving
• Microsoft Office Proficiency
• Timeline Management

PROFESSIONAL EXPERIENCE

Confidential

Office Manager

Responsibilities:

• Planning, prioritizing and scheduling meetings and appointments, answering and screening phone calls.
• Responsible and maintaining of human resources, office operations and procedures; preparing payroll; track attendance and leave for office staff, reviewing and approving supply requisitions.
• Responsible for all accounts payable and receivables.
• Composes and prepares correspondences, memorandums, promotional materials, forms, newsletters, manuals, and reports using appropriate word processing and spreadsheet tools.
• Designing filing systems; organizing patient records and archive to comply with HIPAA guidelines.
• Establishes and maintains working relationship with vendors, insurance companies, and other healthcare facilities/organizations.
• Maintain office efficiency by planning and implementing office systems, layouts, and equipment procurement.
• Design, implement and troubleshoot office policies by establishing standards and procedures; measuring results against standards; making necessary adjustments by gathering related data, analyzing current and past practices.
• Recommends changes in procedures or work flow to improve administrative processes.
• Supervise and create work schedules and assignments for clinical employees; following up on work results.
• Arrange and coordinate travel and travel reimbursement for physicians.
• Manage and ensure website information/content is accurate.

Confidential

Quality Engineer

Responsibilities:

• Accomplished quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; formulated and completed action plans by ensuring safety standards met for all products, confirming product performance or assigning a shelf-life.
• Directed in expediting projects in material conversions, process changes, global manufacturing operations, and contracting manufacturing sites.
• Succeeded product quality by finishing product, system, compliance, and surveillance audits.
• Collaborate with Engineer groups, R&D, QA, Regulatory Affairs, and PQA departments to assure timely project completion by delivering a product shelf-life 3 months before product launch deadline.
• Performed design verification/validation to demonstrate surgical devices are safe and effective for clinical use

Confidential

Quality Analyst

Responsibilities:

• Successfully developed detailed test strategies, test requirements, and functional designs for medical devices; succeeded new product development, improved existing products, and supported new product acquisitions.
• Managed the successful launch of multiple medical devices to market under strenuous timeframe including AccuMesh™ Mesh Positioning System and Parietex™ Composite Ventral Patch.
• Arranged groundwork for an expansion of the AccuMesh™ Mesh Positioning System product line.
• Coordinated surgical operations in North Haven and Ponce, PR to tax advantage; facilitated projects in material conversions, process changes, global manufacturing operations, and contracting manufacturing sites.
• Attained Employee-to-Employee Recognition for Accountability within Surgical Solutions, for displaying exemplary leadership, thorough understanding of the job, and operating well under pressure in a rapidly changing environment.
• Achieved Employee-to-Employee Recognition for Engagement, demonstrating sensitivity to the needs of internal and external customers and prioritizing customer satisfaction.

Quality Technician

Responsibilities:

• Effectively performed quality control assurance activities to comply with applicable SOP's; directed product reliability testing to facilitate continuous improvement, as well as quality inspection procedures, including sampling plans, for production-level components and finished devices.

Valleylab Ligasure Technician

• Assembled vessel-sealing gun and completed equipment inspections; sterilized and packaged surgical equipment for future hospital use.