Jason Cunanan
Staff Quality Engineer, NPI LCM at Mentor Worldwide, LLC, a Johnson & Johnson Company- Claim this Profile
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Bio
Credentials
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Certified Quality Auditor (CQA)
ASQ - World HeadquartersJun, 2016- Oct, 2024 -
Certified Quality Engineer (CQE)
ASQ - World HeadquartersDec, 2014- Oct, 2024
Experience
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Mentor Worldwide, LLC, a Johnson & Johnson Company
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Medical Device
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1 - 100 Employee
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Staff Quality Engineer, NPI LCM
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Mar 2023 - Present
-Partners with Customer Service to ensure the effective implementation of Medical Device Tracking process, leading optimization efforts (system and process) and enforcing compliance to regulations (21CFR821.25).-Ensures active and thorough investigation of quality issues and effective corrective and/or preventive action (CAPA), partnering with R&D, RA and Lifecycle Management and manufacturing teams.-Supports Internal Compliance team as a Team Auditor and conducts internal audits to ensure compliance to established quality systems and regulations. Supports external audit related activities (in the audit backroom) of quality system categories to assess compliance to process excellence standards.-Effectively utilizes Six sigma and Lean Manufacturing tools to solve problems and develop optimal products and processes. Show less
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Sr. Quality Engineer, LCM
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Jan 2020 - Mar 2023
-Partners with Customer Service to ensure the effective implementation of Medical Device Tracking process, leading optimization efforts (system and process) and enforcing compliance to regulations (21CFR821.25).-Ensures active and thorough investigation of quality issues and effective corrective and/or preventive action (CAPA), partnering with R&D, RA and Lifecycle Management and manufacturing teams.-Supports Internal Compliance team as a Team Auditor and conducts internal audits to ensure compliance to established quality systems and regulations. Supports external audit related activities (in the audit backroom) of quality system categories to assess compliance to process excellence standards.-Effectively utilizes Six sigma and Lean Manufacturing tools to solve problems and develop optimal products and processes. Show less
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Johnson & Johnson
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United States
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Hospitals and Health Care
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700 & Above Employee
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Sr. Quality Engineer, QA Complaints
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Apr 2018 - Jan 2020
-Addresses and corrects product and process complaints from multiple manufacturing sites. Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities. -Utilizes multifaceted industry and process excellence standards to implement process improvements within the Quality Complaints Process. -Reports on contract manufacturer performance metrics and ensures management reviews. Oversees audits of all quality system categories to assess compliance to process excellence standards. -Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. -Provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Show less
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B. Braun Medical Inc. (US)
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Quality Engineer
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Oct 2013 - Apr 2018
- Provide/ formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues. Support Corrective Action Preventive Action (CAPA) projects and investigation of root cause for Product Investigation Report (PIR). - Establish investigation and re-start protocols to support product/sub-component disposition utilizing appropriate statistical sampling plan. - Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports. - Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities. - Interface with Engineering, Manufacturing, Regulatory Affairs, Research & Development, and other technical disciplines to represent QA in project teams, with the objective to assure that project quality objectives are met. Show less
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Teva Parenteral Medicines
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Irvine, CA
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Quality Investigator
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Jan 2012 - Sep 2013
- Evaluating all deviation events and determining if each should be escalated to an investigation. If so, responsible for performing the investigation by collecting information from Production and other departments as needed, authoring the deviation report, and creating and monitoring the execution of CAPAs through TrackWise as well as making an immediate disposition to a batch in process if necessary. - Investigating customer related complaints for product quality issues and concerns, including the preparation of written failure investigations. Research batch records associated with the manufacture of the product. - Train and counsel production, facility, maintenance, and engineering personnel to better identify, document, and define events, their need for expedient identification, the need to stop and quarantine as necessary, and the need for immediate notification to the Quality Investigations Department to minimize risk. - Coordinating, conducting, tracking, and resolving company-wide Corrective Action/ Preventative Action (CAPA) investigations. - Investigate continuous compliance to cGMP, GLP, and compliant documentation of all investigations as well as completion of CAPAs on a timely basis leading to better regulatory compliance. Write or revise standard operating procedures as needed. Show less
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Advanced Sterilization Products
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Irvine, CA
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Quality Engineer I
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Jun 2011 - Dec 2011
-Responsible for investigating customer complaints for product quality issues and concerns, including the preparation of written failure investigations. Researched device history records associated with the manufacture of the product. -Worked on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations. -Prepared and performed analysis of customer complaint data and identifies potential product quality trends. Assessed customer complaints for potential regulatory reporting, based on product specific criteria. -Lead effort to identify corrective and preventative actions based on root cause failure investigations. -Participated in design evaluations (FMEAs), in process evaluations (PFMEAs), and in Human Factors evaluations (Health Hazards and System Risk). Devised and implemented methods and procedures for inspecting, testing and evaluating product and will determine and implement solutions to customer issues. Show less
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Fisher and Paykel Healthcare
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Irvine, Ca
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Quality and Regulatory Specialist
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Jun 2009 - Jun 2011
-Provide inbound telephone support for customers by troubleshooting, investigating and resolving customers' questions and inquiries with Fisher and Paykel products and services with an objective of resolving each issue on the first call. -Record and process complaints and inquiries received by mail, telephone, and e-mail. In addition to assist in the tracking and trending of product complaint data for monthly reports and Annual Product Quality Review as directed by Quality Management. -Facilitate calibration and maintenance of test equipment to ensure conformity with regulatory standards. Inspect, repair, and test serviceable items from customers and initiate complaint process where appropriate to ensure equipment is operational and compliant. Complete all reports and documentation detailing the nature of any problems and service and repairs conducted. Show less
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Pacific Contours Corporation
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Anaheim, Ca
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Jr. Manufacturing Engineer
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Sep 2008 - Jan 2009
-Coordinated and assisted in shop floor processes producing close tolerance aerospace components. Typical processes included milling, heat treating, plating, CNC programming, assembly, testing, non-destructive testing, dimensional and visual inspection techniques. -Analyzed and interpreted technical data (engineering drawings, specifications, purchase orders, etc.) to create shop routings, operations sheets, tools, and other necessary processes using JobBOSS to produce a high quality produce. Show less
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California Medical Laboratories
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Costa Mesa, Ca
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Jr. Manufacture Validation Engineer
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May 2008 - Sep 2008
-Oversaw the installation, operation and maintenance of manufacturing equipments of the Engineering and Production Department. -Investigated issues to identify root cause and implemented Corrective and Preventative actions. -Developed equipment documents such as Document Inputs (AutoCAD) and Validation reports. -Oversaw the installation, operation and maintenance of manufacturing equipments of the Engineering and Production Department. -Investigated issues to identify root cause and implemented Corrective and Preventative actions. -Developed equipment documents such as Document Inputs (AutoCAD) and Validation reports.
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Brandywine Student Center Manager
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Jun 2007 - Jun 2008
-Assessed the overall operation and needs of Brandywine Student Center and Helm's Deep with assistance of Program Coordinators. -Managed and advised thirteen Attendants of the BSC and Helm's Deep in programming and customer service efforts. -Assessed the overall operation and needs of Brandywine Student Center and Helm's Deep with assistance of Program Coordinators. -Managed and advised thirteen Attendants of the BSC and Helm's Deep in programming and customer service efforts.
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Education
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2010 - 2013
California State University-Fullerton
Masters, Mechanical Engineering -
2004 - 2009
UC Irvine
Bachelors, Mechanical engineering
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