NIKKI ANN BALASON
MISSION VIEJO,CA
Summary
- Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
- To obtain a position where I could utilize my skills, have a room for growth, and be part of an organization that has proven success in its field and at the same time contribute to its productivity.
Overview
7
7
years of professional experience
Work History
SR. QUALITY TECHNICIAN CAL AND PM
NUVASIVE SPECIALIZED ORTHOPEDICS
09.2023 - Current
- Performed preventative maintenance and inspections on production machinery.
- Schedules to calibrate machines to maintain required productivity levels and adherence to quality standards.
- Recorded and documented all maintenance activities in accordance with company policies and procedures.
- Schedules general equipment maintenance and repair to minimize downtime.
- Read worker logs, product processing sheets or specification sheets to verify records adhered to quality assurance specifications.
SR. QUALITY TECHNICIAN
NUVASIVE SPECIALIZED ORTHOPEDICS
07.2022 - 09.2023
- Supports the organization with initial compliance and ongoing preparation, testing and monitoring of product conformance to established quality assurance processes and standards
- Performs functions associated with quality control and quality assurance operations, including carrying out rework and quality assurance procedures related to production or operations
- Determines and assists in developing methods and procedures for quality assurance and control
- Executes the product quality complaint investigation and conducts failure investigation reports together with Quality Engineer
- Developed and implemented quality control processes to meet product standards.
- Performs investigations for quality/compliance related matters and partners with Quality and Product supply to bring issues to a timely close, providing follow-up to internal and external customers as needed
- Performs data analyses to support reports for internal and external customers, as needed
- Performs other duties as assigned
- Strong understanding of quality system requirements and topics, including trends in the medical device industry pertaining to compliance
- Possesses the ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Proficient with ASME Y14.5M GD&T and blueprint reading
- Strong communication skills with the ability to speak effectively to internal and external teams
- Proficient and accurate with MS Office applications, flow charting, and graphs
- Solid understanding of good documentation practices and record retention strategies, as well as an understanding of the requirements to work in a Cleanroom/Sterile packaging environment
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
- Developed and implemented process improvements to meet product quality standards.
QUALITY INSPECTOR II
GLAUKOS CORPORATION
01.2021 - 07.2022
- Works with Engineering in the design of high-quality inspection and Metrology Fixtures
- Utilize a variety of standard metrology equipment, including: CMM, VMS (Smart scope), Keyence, Calipers, micrometers, surface tables, gauge blocks, pin gauges, measuring microscope, pull force testers (Instron), dial indicators, durometer, hardness testers, etc
- Handle and process extremely small components without damaging them
- Ensures daily basis quality records and company practices are compliant with internal procedures and regulations
- Receiving inspection of components from different vendors, following procedures, specifications, and drawings
- Support equipment and process validations and first article activities by inspecting process outputs
- In-process inspection to support manufacturing needs.
- Discarded and rejected products, materials and equipment not conforming with specifications.
- Identified and helped resolve non-conforming product issues.
- Inspected incoming and outgoing materials for accuracy and quality.
- Communicated with production team members about quality issues.
- Inspected products with accuracy, reporting problems or defects quickly.
MANUFACTURING TECHNICIAN II
GLAUKOS CORPORATION
02.2019 - 01.2021
- Building and preparing components, subassemblies, and top-level assemblies.
- Completes documentation like DHRs and input data into an MRP System.
- (Oracle) Assembly and disassemble process equipment following written instructions and SOPs.
- Tray Sealing – Final Assembly
- X-ray Finished Goods
- Packaging Finished Goods
- Assembled and tested parts and components to meet safety and performance standards.
ASSEMBLER I
MICROVENTION TERUMO
03.2018 - 01.2019
- Performs the assembly or sub-assembly of medical devices and products in an advanced position under moderate supervision from line leaders and supervisors in accordance with manufacturing documents & verbal instructions
- Using written and verbal instruction to assemble and package product
- Records data associated with the building of product on builds records
- Ability to meet quality standard
- Perform job function within production standard on 2-5 operations
- Work with engineers and supervisors to perform special assembly requests.
ASSEMBLER I
MEDTRONIC
02.2017 - 02.2018
- Performs a variety of tasks ranging from repetitive to non-repetitive production assembly operations
- Works from visual aids, method layouts, diagrams, schematics, process flow sheets and written or verbal assembly instructions
- Sets initial layouts and uses a variety of tools to prepare product(s)
- Makes continuity checks on work in process and completed.
- Followed outlined specifications to implement assembly plans.
- Assembled parts correctly according to specifications, reducing quality issues.
- May conduct quality inspections on processing line in accordance with quality specifications
- May disassemble, modify, rework, reassemble, and test experimental or prototype assemblies and subassemblies according to specifications and under simulated conditions
- Inspection of Final Assembly.
Education
No Degree - Tourism Management
DE LA SALLE
Lipa City, Philippines2016
High School Diploma -
SAINT BRIDGET COLLEGE
Batangas City, Philippines03.2015
GED -
UNIVERSITY OF BATANGAS
Batangas City, Philippines03.2008
Skills
- Specifications Understanding
- Product Sampling
- Inspections and Reviews
- Documentation Skills
- Visual Inspection
- Quality Issue Identification (Complaints)
- Smartscope Certification
- Verbal and Written Communication
- Microsoft Office
- Attention to detail and accuracy, GDP, Process Improvements
- Oracle, QAD, Cebos, EtQ
- Validation and First Article Inspections
Languages
English
Professional Working
Filipino
Native or Bilingual
Timeline
SR. QUALITY TECHNICIAN CAL AND PM
NUVASIVE SPECIALIZED ORTHOPEDICS
09.2023 - Current
SR. QUALITY TECHNICIAN
NUVASIVE SPECIALIZED ORTHOPEDICS
07.2022 - 09.2023
QUALITY INSPECTOR II
GLAUKOS CORPORATION
01.2021 - 07.2022
MANUFACTURING TECHNICIAN II
GLAUKOS CORPORATION
02.2019 - 01.2021
ASSEMBLER I
MICROVENTION TERUMO
03.2018 - 01.2019
ASSEMBLER I
MEDTRONIC
02.2017 - 02.2018
No Degree - Tourism Management
DE LA SALLE
High School Diploma -
SAINT BRIDGET COLLEGE
GED -
UNIVERSITY OF BATANGAS
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