Marie Garcia
Oceanside,CA
Summary
Organized and motivated employee eager to apply time management and organizational skills in various environments. Seeking entry-level opportunities to expand skills while facilitating company growth.
Overview
20
20
years of professional experience
Work History
Quality Manager
Superior Machine Products
08.2018 - Current
- Standardized the document control procedure
- Made it more manageable with the use of more structured, well-defined with documentation steps
- Performed internal process audit on various product groups to endure conformance to work instructions, customer specifications, safety standards, and ISO 13485 requirements
- Established new procedures for Final Inspection Process
- Designed new fixtures for testing equipment
- Traveled to facilities, on some occasions, to conduct special audits and to provide one-on-one training with Quality Personal
- Wrote, edited and trained employees on work instructions
- Worked with engineers to reduce reworking final product
- Conduct Non-Conformance Reports from Identifying the issue, to Opening a report performing MRB meeting, and seeing the flow to close
- Making sure the shop and QC are trained to performs all duties in compliance to ISO 13485
- Report all status of Items in QC to management, Managing all Priorities to insure a timely release of Products
- Coordinate and identify opportunities to make process faster and better without risking quality
- Keeping accurate records of calibration and Inspections.
Sr. Quality Specialist
Alphatec Spine
05.2012 - Current
- Using CMM (Brown & Sharp CMM PC DMIS program and Smart Profile)
- Experience conducting First article reports, travelers and any other documentation needed for this Process
- Designed new and effective ways to improve the quality of the product while reducing the downturn
- Oversee Receiving inspection
- Ensured regulatory procedures and changes were documented and followed according to customers’ requirements
- Maintain accountability of all inspectors work inside lab and shop floor
- Conformance to FDA and ISO Requirements
- In-process inspection (dimensional inspection production floor audits)
- Train inspections to second Operations (Anodize, Laser Etch, Bead Blast ext)
- Work close with planning, scheduling workload and Priorities
- Working under FDA regulatory procedures and standards
- Processing and routing NC Reports Until Closed
- Review and approve analytical method validation protocols and reports
- Using Agile Oracle and Vantage Lot tracking systems
- Comply with safety Rules and Regulations for all Inspectors
- All other duties as Requested by QC Management.
Quality Control/Assurance Inspector III
Sea Spine/Integra
06.2010 - 05.2013
- Experience conducting First article reports, travelers and any other documentation needed for spinal Implants by the supplier
- Inspecting R&D, New Development and Prototyping
- Inspected with accuracy to meet short deadlines for surgeries
- Inspected and Supplied Instruments for Cadaver Lab.
Quality Control/Inspector Assurance III
Alphatec Spine
06.2008 - 06.2010
- Executed technical inspections in the production process
- Prepared visual incoming first article and final inspections
- Assist with some calibration of shop tools
- Supported troubleshooting and participated in Quality survey requests
- Verified compliance to customer drawings specs and additional requirements
- Operate automated measuring machine that could include and of the following: CMM (Coordinate Measuring).
QC Inspector III
Cameron Health
01.2006 - 01.2008
- Verified compliance to customer drawings specs and additional requirements
- Assemble electrical chips using adhesive material
- Visual inspection of high level and detail inspection of raw materials and electronic components
- Inspection Done on heart Infibulates (ESD Certified).
Quality Assurance Inspector III
Zimmer Dental
01.2004 - 01.2006
- Carried out and documented first piece in process and final inspections; determined and reported and non-conformances
- Maintained all necessary quality records and documents
- Perform part layouts gage calibrations Gage R&R's utilizing Gage Track system
- Experience inspecting parts made from different material such as aluminum, Titanium, Delrin , Stainless Steel and others
- Worked with engineer to develop new fixtures for the machines, also helped in improving quality processes
- Conduct documentation and writing non-conformant reports on defected parts to separate the good parts from the bad
- This report also showed measurement findings
- Performed gaged R and R.
Skills
- Operational Improvements
- Documentation Control
- Team Training
- SOP Development
- Quality Processes
- Document Management
- Problem-Solving Abilities
- Continuous Improvement
- Staff Management
- Process Improvement
- Team Leadership
- Good Judgment
Timeline
Quality Manager
Superior Machine Products
08.2018 - Current
Sr. Quality Specialist
Alphatec Spine
05.2012 - Current
Quality Control/Assurance Inspector III
Sea Spine/Integra
06.2010 - 05.2013
Quality Control/Inspector Assurance III
Alphatec Spine
06.2008 - 06.2010
QC Inspector III
Cameron Health
01.2006 - 01.2008
Quality Assurance Inspector III
Zimmer Dental
01.2004 - 01.2006