Nick Martinez
San Juan Bautista,CA
Summary
Results-driven professional with 30+ years of experience in FDA and ISO 13485 regulated facilities. Expertise in Quality Control and Assurance Management, including overseeing inspections of raw materials, in-process, and finished goods. Proven track record of maintaining and supporting quality systems while ensuring compliance with customer and regulatory requirements.
Overview
22
22
years of professional experience
Work History
Quality Manager
KETTMANN MACHINING, Inc.
San Jose, CA
01.2022 - Current
- Host and support all customer and ISO 13485 regulatory audits.
- Provide support to the QMS once implemented for production and new products in development.
- Lead process validation and implement supplier agreements that ensure quality standards.
- Discuss inspection results with those responsible for products, and recommend necessary corrective actions.
- Develop corrective action plans for nonconforming product and develop process improvements.
- Manage and Approval of DHR’s (Device History Record) process.
- Perform in-house 13485 audits to support IQMS
- Oversight of the corrective action system, including determining the root cause and implementing a solution.
- Completion of in-house NCR’s and customer SCAR’s
- Audits of the International Standards and regulatory audits
- System maintenance
- Managing the calibration department ensuring all devices are properly utilized and are calibrated and maintained
- Work in partnership with manufacturing to ensure proper training and inspection of parts at the machines, and establishing proper protocols for in-process inspections.
- Developed and implemented quality management systems to ensure compliance with customer requirements.
- Performed internal audits of production processes to identify areas of improvement and non-conformities.
- Monitored product performance against customer specifications and standards, ensuring that all products met the required standards.
- Ensured effective implementation of corrective actions to resolve any identified issues or discrepancies in a timely manner.
- Provided technical guidance on quality control activities to support efficient operations.
- Prepared reports summarizing findings from inspections, tests, investigations and other QA activities for senior management review.
Quality Supervisor
KETTMANN MACHINING, Inc.
San Jose, CA
10.2019 - 01.2022
- Supervise daily operations of QA department in a machining/Manufacturing environment
- Monitor and measure day to day operations of QA staff to understand available capacity
- Verify shipping documentation post Clean Room/prior to shipment
- Develop sampling plan for all parts ie
- Supervise the inspection department in performing all test and checks while ensuring proper accepted sampling techniques are used and all paperwork is accurate and complete
- Supervising quality personnel, including training, evaluation and contribute to hiring and firing decision within the quality department
- Provide support to the Quality Management System (QMS) once implemented for production and new products in development
- Discuss inspection results with those responsible for products; and recommend necessary corrective actions
- Develop corrective action plans for non-conforming product and develop process improvements
- Review and approve Customer Certification of Compliance documents prior to shipment
- Approval of DHR’s (Device History Record)
- Responsible for writing 90 day and annual performance reviews
- Perform in-house 13485 audits to support IQMS
- Oversight of corrective action system including determining root cause and implementing solution
- Completion of in-house NCR’s and customer SCAR’s
- Ensuring all devices are properly utilized and are calibrated and maintained
- Work in partnership with manufacturing to ensure proper training and inspection of parts at the machines and establishing proper protocols for in process inspections.
Lead IQC Inspector
THINK Surgical Inc.
San Jose, CA
07.2015 - 10.2019
- Perform incoming, in-process and final inspections, perform a wide range of complex or precision inspection procedures to determine quality levels of incoming parts or products at various stages in production, including final acceptance
- Initiate NCMRs for non-conforming materials/products; Manage weekly MRB meeting to disposition non-conforming material
- Provide input to Quality Engineering regarding inspection methods, quality procedures, and sampling plans, manage inventory and work with planning for incoming parts and engineering projects
- Executes other quality projects and non-routine duties as assigned by the QA manager.
Sr. IQA Inspector
Xoft Inc.
San Jose, CA
10.2013 - 06.2015
- Incoming inspection of raw materials, in-process and final inspection
- Knowledge of GD&T drawings and use of MicroVu, calipers, micrometers, snap gauge, pin gauges and Instron Material Testing unit
- Maintaining Calibration schedule, use of Agile system to create non-conformance's
- Qualify parts for Dock-to-Stock based on Quality System requirements
- Assist Quality Manager on Supplier Audits.
Sr,. IQA Inspector
Intuitive Surgical
Sunnyvale, CA
06.2013 - 10.2013
- Inspection of incoming materials, performed first article inspection and general inspection for compliance to drawings
- Interpreted geometrical tolerances in drawings and part specifications, utilized Agile and SAP for system transactions
- Issue non-conforming parts to MRB
- Use of Mitutoyo Comparator and Vision System as well as calipers, micrometers, gauges, pins to perform inspections.
Sr. IQA Inspector
Abbott Diagnostics Division
Santa Clara, CA
06.2011 - 03.2013
- Inspect complex incoming materials-Mechanical, Electrical, Chemical and Purchase parts for conformance to requirements
- Interprets geometrical tolerances in drawings and part specifications
- Utilizes Oracle software to inspect parts and disposition material into proper inventory location
- Retrieve data and history for internal and external customers in relation to product.
Quality Specialist 2
Abbott Labs (ADC)
Alameda, CA
06.2010 - 03.2011
- Inspection of raw materials and finish goods based on specifications to assure conformance to regulatory requirements
- First article, general and reduced inspections based on product specification (knowledgeable of reading GD and T drawings)
- Strip Calibration and Data Analysis for product performance and acceptability.
Senior Incoming Quality Assurance Technician
LifeScan, Inc
Milpitas, CA
08.2002 - 10.2009
- Have a clear understanding of a QSR (Quality System Regulated) FDA environment, able to work effectively with multi-departmental personnel to assure conformance to regulatory requirements
- Inspection of raw materials and finished goods from external manufacturers
- Performed First Article, Drop Shipment and Dock-to-Stock inspections to cGMP and quality requirements
- Created and updated databases for equipment calibration, inspection records and archives
- Update department procedures SOP's, GOP's and WI's for process improvements and Compliance
- Created new processes and procedures for internal and external customers
- Oversaw 'Dock-to-Stock' process to ensure compliance and managed monitoring requirements and oversaw quarterly committee meetings to discuss and identify any opportunities for process improvement
- Work with various suppliers to identify any issues and or product launch commitments to meet business goals
- Initiated and supported multi-departmental projects and validations that meet our quality and compliance standards
- Initiated, investigated and closed all system and product related non-conformances within the NCR and CAPA process.
Education
Diploma -
Yerba Buena High School
San Jose, CA06.1992
Associate of Science - Business Management
San Jose City College
San Jose, CASkills
- Customer Service
- Project Planning
- Human Resources Management
- Policy administration
- Business Administration
- Emergency Response
- Process Improvement
- Staff Management
- Employee Development
- Team Building
- Employee Coaching and Mentoring
Accomplishments
- Successful completion of the Production Part Approval Process (PPAP) of customer request of medical device. All 18 elements were included to ensure that the supplier understands the customer's design and can consistently produce parts that meet all requirements.
- Retainement of the ISO 13485 certification.
- Completion of pFMEA's and Process Capability at customer request.
Timeline
Quality Manager
KETTMANN MACHINING, Inc.
01.2022 - Current
Quality Supervisor
KETTMANN MACHINING, Inc.
10.2019 - 01.2022
Lead IQC Inspector
THINK Surgical Inc.
07.2015 - 10.2019
Sr. IQA Inspector
Xoft Inc.
10.2013 - 06.2015
Sr,. IQA Inspector
Intuitive Surgical
06.2013 - 10.2013
Sr. IQA Inspector
Abbott Diagnostics Division
06.2011 - 03.2013
Quality Specialist 2
Abbott Labs (ADC)
06.2010 - 03.2011
Senior Incoming Quality Assurance Technician
LifeScan, Inc
08.2002 - 10.2009
Diploma -
Yerba Buena High School
Associate of Science - Business Management
San Jose City College
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