Rachel Kangas
San Jose
Summary
Quality assurance professional with strong foundation in quality control and process improvement. Known for keen eye in detecting discrepancies and driving initiatives that enhance product quality. Valued team player who excels in collaborative environments, consistently delivering reliable results and adapting to dynamic project requirements.
Overview
16
16
years of professional experience
Work History
Quality Assurance Associate
Atia Vision, Inc.
08.2016 - Current
- Supported continuous improvement efforts by actively participating in process reviews and suggesting data-driven recommendations for enhancement.
- Communicated effectively with suppliers to address any discrepancies found during incoming material inspections, fostering strong working relationships and better supply chain management.
- Assessed quality of finished products with careful inspections.
- Assisted in the creation of quality standard operating procedures, promoting uniformity across all departments and reducing ambiguity in expectations.
- Collaborated with managers to write procedures for R&D and Operation departments.
- Released finished products after reviewing samples for medical device.
- Maintained quality records for compliance and analysis purposes.
- Assisted in the development of training materials, boosting employee understanding of quality standards and expectations.
- Collaborated with team members to develop robust test plans, ensuring comprehensive coverage of all critical features.
- Promoted a culture of attention to detail within the team by emphasizing the importance of precision in all aspects of work.
- Participated in cross-functional meetings to ensure alignment between quality assurance objectives and overall company goals, fostering a collaborative working environment.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Performed tests and inspections to conform to established standards.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Performed routine maintenance and calibration on testing equipment.
Quality Assurance
Zipline Medical
10.2014 - 08.2016
- Reviewed and closed Device History Records, Non-Conformance Reports, Document Change Orders, Customer Complaints and CAPAs.
- Facilitated employee training process; worked with cross functional team to streamline the training process, ensuring that employees are trained within the required amount of time.
- Inspected and Released and labeled subassembly components for further use in builds.
- Inspected and Released Final Assembly product for sale and shipment to customers.
- Worked with Engineering to update and streamline Manufacturing Process Instructions, Forms and Work Instructions.
- Created Certificates of Conformance for shipments of products and components.
- Assisted Customer Service, Shipping/Receiving and R&D departments in various projects.
Quality Control Inspector
Boston Scientific
02.2014 - 11.2014
- Reviewed and closed Device History Records, Non-Conformance Reports and Special Manufacturing Authorizations (SMA).
- Facilitated SMA process; worked with cross functional team to streamline the Special Manufacturing Authorization process, ensuring that SMAs are closed before product release.
- Released and labeled subassembly components for further use in builds.
- Inspect and documented packaging per the Manufacturing Process Instructions.
- Worked with Engineering to update and streamline Manufacturing Process Instructions, Forms and Work Instructions.
- Created Certificates of Conformance for shipments of products and components.
- Maintained stock of materials needed in the department.
- Sent components and finished devices for chemical and biological testing.
Quality Control Inspector
West Valley Precision
07.2013 - 12.2013
- Inspected manufactured parts per ISO, GD&T and ANSI standards.
- Created and populated First Article Inspection Reports.
- Worked with vendors to get the best quality of coatings, plating, painting, engraving, and finishes on parts.
- Closed Non-Conformance Reports and maintained the Non-Conformance Report system; generated trend analysis to assist in determining the reliability of the preventative maintenance of manufacturing machines.
- Created, edited and released Manufacturing Process Instructions, Work Instructions and Forms.
- Assisted Quality Manager with Corrective Action Reports, and Supplier Corrective Action Reports review and closure.
Lead Inspector
Wightman Engineering Services
07.2009 - 11.2012
- Inspecting parts in accordance to ISO 9000, ISO 13485, GD&T, ASME, and Military Standards.
- Inventory and send all inspection tools for calibration as needed.
- Calibrating all inspection tools in accordance to Military, ISO, and ASME standards.
- Programming and running the Mitutoyo CMM on a MCOSMOS system; The Vision System, and the Micro Vu system.
- Create training records and train team members on processes and procedures of the shop.
- In process inspection including, Pre-controls, SPC CPK data collection, and paperwork audits.
- Creating and filling out FAIR paper work in accordance to AS9002, and specific customer requirements.
- Auditing shipping and receiving paperwork, including incoming inspection and Certificates of Compliance.
Education
Santa Clara High School
Santa Clara06-2002
Skills
- Raw material inspection
- Inspections
- Defect tracking
- Technical aptitude
- Sampling
- Software testing
- Problem-solving skills
- Team collaboration
- Manual testing
- Verbal and written communication
- Detail-oriented
- Quality improvements
Timeline
Quality Assurance Associate
Atia Vision, Inc.
08.2016 - Current
Quality Assurance
Zipline Medical
10.2014 - 08.2016
Quality Control Inspector
Boston Scientific
02.2014 - 11.2014
Quality Control Inspector
West Valley Precision
07.2013 - 12.2013
Lead Inspector
Wightman Engineering Services
07.2009 - 11.2012
Santa Clara High School
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