Mai Kia Yang
Ogilvie,MN
Overview
14
14
years of professional experience
Work History
Quality Control Specialist II
Halozyme
02.2022 - Current
- Updated inspection journals and daily summary logs with quality-related data.
- Collected and analyzed data to measure effectiveness of quality control processes.
- Performed tests and inspections to conform to established standards.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Created and maintained several databases to track statistical data.
- Suggested improvements to designs and documentation to improve product reliability and manufacturability.
Quality Inspector IV
Stryker
11.2021 - Current
- Read blueprints, follow inspection processes, and SOP’s in compliance to GMP/GDP and FDA regulatory requirements; prior to release of raw materials and finished goods
- Utilized gauges, tools, and vision systems to perform dimensional and/or visual inspections, using AQL sample plans
- Initiate nonconformances, and coordinate issue resolution or process improvements with Quality Engineers, Quality Management, or suppliers
- Prioritize weekly/monthly workload according to schedule; including inspection of pre and post sterilization, final inspection, and inspection of raw materials for production and business needs
- Have knowledge of doc control, dispositions, documentation review, lot traceability, create purchase orders and ASN, redline documents, TrackWise, QAD, onePLM, and Approved Supplier Lists.
Instrument Builder II
Emerson
03.2018 - 10.2021
- Built, tested, and calibrated pressure transmitters following written instructions and BOM; using hand tools, torque guns, and automated equipment
- Performed in-process and final inspection to ensure products met stringent processes and procedures
- Recognized and initiated nonconformances for repair.
Medical Device Assembler
Boston Scientific
11.2017 - 03.2018
- Followed detailed assembly processes and procedures to assemble medical devices, while visually inspecting parts for defects.
Inspection
Heraeus
07.2014 - 03.2015
- Inspected 100% of materials and finished parts for defects using measuring instruments such as rulers, calipers and gauges to measure dimensions of materials and products to ensure materials met customer specifications and tolerances
- Performed routine line checks to ensure quality control
- Labeled and packaged finished goods in preparation for shipping.
Medical Assembler
Colder Products Company
03.2010 - 05.2014
- Followed detailed assembly instructions, processes and procedures to build medical devices
- Visually inspected and tested devices for defects.
Education
Bachelor of Science -
Saint Paul College - Transfer Pathway To Metro
Saint Paul, MN11.2026
Associate of Science - General studies
Century College
Saint Paul, MN09.2014
GED -
Harmony Learning Center
Maplewood, MN08.2012
Skills
- Quality Control Principles
- Documentation and Reporting
- Regulatory Compliance
- ISO 13485
- Class I/II medical device
- Quality Auditing
- MS Words, Excel, Outlook, Teams
- Process Improvement
- GMP/GDP
- CAPA
- 5S Methodology
- Decision-Making
- Planning and Coordination
- Organization and Time Management
- Documentation Review
- Data Analysis
- Sampling
- Test Planning
Timeline
Quality Control Specialist II
Halozyme
02.2022 - Current
Quality Inspector IV
Stryker
11.2021 - Current
Instrument Builder II
Emerson
03.2018 - 10.2021
Medical Device Assembler
Boston Scientific
11.2017 - 03.2018
Inspection
Heraeus
07.2014 - 03.2015
Medical Assembler
Colder Products Company
03.2010 - 05.2014
Bachelor of Science -
Saint Paul College - Transfer Pathway To Metro
Associate of Science - General studies
Century College
GED -
Harmony Learning Center
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