Quality Assurance

Glenn P. Kinney

978-***-**** *** Rocky Ridge Drive

***************@*****.*** New Braunfels, TX 78130

Summary of Experience

ASQ Certified Manager of Quality / Organizational Excellence / ASQ Certified Quality Auditor

Develop, implement and manage QSR 21CFR 820, ISO 13485, ISO9001 compliant programs

CAPA program: 8D, root cause investigation, corrective action, verification and closure

Incoming, in process and final release inspection activities / First Article Inspection

Develop and perform QSR / ISO, Inspection and Process training

Administer, supervise and execute internal, supplier and third party auditing

Batch record review and product release

Manage internal and external calibration programs

Quality liaison for military and medical device customers

Write, review and approve quality system procedures

Achieved ISO certification in two organizations

Experience

Senior Quality Systems Engineer Jan. 2015 to Jan. 2017

MKS Instruments Inc. Andover, MA

Manage Quality System and external certifications: system and product

Manage customer and regulatory audits: agenda, prepare owners, corrective actions

Chair and organize Management Review meetings

Work with Department Managers to implement regulations, standards and system requirements

Manage Corrective Action Preventive Action Program: assignment, tracking, monitoring and closure

Manage SSQA Standardized Supplier Quality Assurance program

Training for all levels of personnel: ISO, Quality Projects, Quality Systems, Orientation

Manage Internal Audit program

Manage Document Control Database (lotus notes)

Develop and manage metrics: Inspection, CAPA, Audits

First Article Inspection

Quality Assurance Specialist July 2014 to Nov. 2014

AdvanDx Woburn, MA

Design and develop Quality System policies and procedures

Batch Record Review / Product Release

Manage Product and Quality System Records

Manage CAPA and NCMR programs / investigations and effectiveness monitoring

Manage Training program

Supplier Management

Senior Quality Systems Analyst March 2012 to July 2014

Fresenius Waltham, MA

Design and develop Quality System policies and procedures

Manage internal audit program at Waltham Corporate facility

Manufacturing site auditing

Supplier auditing

Prepare Metric Trending Plans and analyze Quality System compliance

Support staff during FDA audits and ISO auditor escort

CAPA containment, root cause analysis, effectiveness monitoring and closure across all facilities

Quality Assurance Engineer March 2010 to March 2012

Parlex Corporation (A division of Johnson Electric) Methuen, MA

Manage Quality Assurance programs

CAPA containment, root cause analysis, effectiveness monitoring and closure

Internal Audits

Training on quality systems, CAPA, ESD and customer and internal auditing

Manage Quality Control programs

Calibration program

Incoming and In-process Inspection

Customer Quality Liaison

Source Inspection liaison (military)

Quality related issues and new product development

Perform finished Product Release

Perform First Article Inspection AS9102

Lead Gemba Kaizen improvement process teams

Design and develop Quality System procedures and production documentation

Quality Assurance Project Manager March 2007 to March 2010

DEKA Research and Development Manchester, NH

Managed CAPA and Internal Audit program

Supplier auditing

Monitored Design Control processes for medical devices through concept, qualification, human use and transfer to Manufacturing.

Customer and external auditor liaison

Quality Assurance Specialist Oct. 2006 to March 2007

Bionostics, Inc. Fort Devens, MA

Managed CAPA and Internal Audit program to ISO 13485 and QSR requirements.

Developed and wrote Quality System procedures and Device Master Records.

Quality Engineer (6 month contract position) Feb. 2006 to Aug.2006

Diamond Staffing Worcester, MA

Trained QA and Manufacturing Engineering personnel in CAPA activities

Review, disposition, approve, and close Corrective Action reports

Interacted with medical device clients to ensure corrective actions effectiveness

Performed internal, product, and process auditing

Developed and wrote Quality System procedures to QSR, ISO13485, and ISO 9000 requirements

Developed and wrote inspection procedures for new and existing product lines

Quality Manager 2001 - 2004

Hyaluron, Inc. Woburn, MA

Developed and implemented a QSR and ISO compliant Quality System for a start-up medical device contract manufacturing company

Batch record review and final product release

Managed Document Control, Material Review Board (MRB), and CAPA functions

Managed incoming, in-process and release inspection activities

Performed internal and supplier auditing

Quality Management representative

Project Manager for new clients

Quality Systems Specialist 1999 - 2001

Parexel Waltham, MA

Corrective Action projects for organizations under FDA consent decrees

Performed third party review for manufacturing, Document Control, and Quality System activities

Trained technical and management personnel in QSR and ISO requirements

Conducted comprehensive Quality System audits to QSR requirements for clients

Prepared and reviewed Standard Operating Procedures (SOPs)

Performed data analysis, day-to-day management, and scheduling of assigned projects

Recommended corrective actions for medical device and pharmaceutical clients and suppliers for Quality System, material, and process deviations

Third party Batch Record review prior to product release

Previous work experiences includes QA/ QC Manager, Inspection Supervisor and Quality Systems Auditor positions at several established and startup companies including small, medium and large sized organizations. Experienced increasing roles of responsibility and influence ensuring compliance with internal and regulated requirements and standards. A full listing of my work history is available upon request.

Education

Bachelor of Science, Business Management, cum laude, Emmanuel College, Boston, MA

Certifications

ASQ Certified Manager of Quality / Organizational Excellence certification number 11698

Certified Six Sigma Green Belt certification number 10521

ASQ Certified Quality Auditor, certification number 15084

Contact this candidate