WORK EXPERIENCE:

Confidential

Quality Assurance Supervisor

Responsibilities:

• Excellent verbal, interpersonal and written communication skills
• Self - starter, and motivated individual who works independently
• Assures compliance to external and internal Quality Standards for Manufacturing and Product Development.
• Creates and applies policies and procedures for identifying, analyzing risk throughout teh product life cycle.
• Conducts evaluations, tests and makes decisions to maintain Quality Objectives.
• Designs and install Quality Processes, Procedures and Techniques.
• Monitors and resolves Internal Non Conformities (NCMR), Deviation Report (DA), Corrective and Preventative Actions (CAPA), Supplier Corrective Action Report (SCAR), Field Report (FR).
• Perform audits and investigations of products, services or internal processes in order to identify and correct issues causing non-compliance of product to specification, escape of non-conformances to customers or inTEMPeffectiveness of a business system to achieve its intended purpose.
• Interview and recommend employees selected for hire or promotion to meet production schedule.
• Recommend changes in compensation and grade level.
• Administer work rules, safety regulations, manage daily employee performance, and conduct periodic performance feedback to ensure productive workforce.
• Confer wif other managers to resolve worker problems, complaints or grievances.
• Identify personnel for lead operator role, prepare lead operators for their role, monitor teh lead operators for operator relations and team performance.
• Confer wif other managers to coordinate operations and activities wifin or between departments.

Confidential

Manufacture Engineering

Responsibilities:

• Knowledge and skill in engineering documentation procedures, development methods and project management, wif teh ability to rapidly master company internal procedures and methods, such as Documentation System, ECOs, DOEs, DVTs, DRs/DAs, etc.
• In charge of MRB and establish projects to reduce scrap.
• IPC-A-610, IPC-J-Standard, and IPC-A-620 Certified Trainer.
• Ability to utilized Oracle to perform components analysis and traceability.
• Maintain and update incoming inspection files, procedures, and related required documentation.
• Determining proper product configuration and performance using engineering instructions such as product Prints (DWG), Inspection Plans (IP), Routers (R), Manufacture Procedures (PM).
• Compiling and evaluating statistical data to determine and maintain quality and reliability of products.
• Supporting internal and external audits.
• Development and implementation of corrective actions to prevent reoccurrence of nonconforming product.
• Developing and initiating standards and methods for inspection, testing, and evaluation of incoming, in-process and finished goods for new and existing products.
• Facilitating process validation and teh implementation of SPC in manufacturing.
• Depth of knowledge of SOPs, GMP/FDA/ISO 9000 principals and proven skill in integrating into engineering discipline.
• Problem solving skills to rapidly determine root cause.
• Using various tools and equipment to trouble shoots mechanical/electronic devices.
• Ability to work wif engineering staff members and Operations personnel in an TEMPeffective and positive manner and to provide basic on-teh-job technical to others in teh department; ability to clearly convey ideas and concepts.

Confidential

Quality Technician

Responsibilities:

• Performing Final Inspection and First Article Report (FAIR) validation process for internal and/or external suppliers.
• Specialize in inspecting Medical Device such as Cardiology, Endoscopy and Orthopedics related devices.
• Inspecting medical parts produce from Swiss lathe, Citizen, and Star CNC machines.
• Ability to use and understand applicable Inspection Measuring and Testing Equipment, for example micrometers, comparator, blade micrometer, thread ring/plug gages, pin micrometer, drop indicator calipers, test indicator, bench micrometer, pressure A, microscope, broach gage, pin gages, concentricity gage, bore gage, tool maker microscope, flange micrometer, Quadra check, programmable Vision System, profolometer, and coordinate measuring machine (CMM).
• Ability to apply appropriate Acceptable Quality Level (AQL) as sampling plans/strategies to certain Inspection.
• Ability to utilize current business software applications; to include but not limited to: word Processing software, spreadsheet/statistical applications, web browsing applications, KABA, Oracle,
• Statistical Process Control (SPC), Creates new statistical software files as needed for data in-put and analysts.
• Understands and applies statistical process control techniques, including basic chart interpretation and capability analysis.
• Well known Good Manufacturing Practice Regulations (GMP)
• Responsible for coordinating, tracking, and trending supplier certified raw material components.

Confidential

Manufacture/Quality Lead (Promotion)

Responsibilities:

• Certified as a Production Lead
• Direct and coordinate teh activities of employees engaged in teh production or processing of goods to include Inspectors, Setup Technicians, Quality Auditors, and Production Operators. Plan and establish work schedules, assignments and production sequences to meet scheduled production goal.
• Communicate TEMPeffectiveness of executing production schedule and performance of teh production staff by work area to teh production staff.
• Direct teh work of shift technician set-ups and quality audits.
• Observe production work to ensure that operators and lead operators conform to production or processing standards.
• Interpret specifications, blue prints, and job orders, set up, and operate SMT, wave solder machines, and company policies to all shift workers.
• Address equipment issues and recommend process improvements.
• Monitor and adhere to production schedules and report daily production statistics such as units per hour, yield, and employee attendance.
• Inspect materials, products, or equipment to detect defects or malfunctions.
• Demonstrate equipment operations and work and safety procedures to new employees, or assign employees to experienced workers for .
• Responsible for all other duties as assigned and enforce safety regulations
• Well known ISO Quality Management System requirements.