Larry N Decker

**** * ****** **, #*** Tucson AZ 85704 ■ M: 973-***-****

admjvx@r.postjobfree.com

Manager – Quality Assurance

Quality manager with successful experience leading operations and procurement in quality assurance/compliance within large corporate environments – generating significant cost savings. Successful in implementing, standardizing, and streamlining processes, policies, and procedures to maximize customer service performance and quality across operations by reducing supplier variation and addressing customer concerns. Highly effective at building and directing cross-functional teams to design and deploy corporatewide, compliant quality systems vital to maintaining FDA Compliance and ISO certifications. Recognized for developing, coaching and mentoring less experienced associates. Excel at devising and executing compliance tools and business solutions to deliver increased quality, productivity, and ROI. Exceptional skills in process and supplier management, key performance measurement, strategic sourcing strategies, and customer service resolution.

Core Leadership Competencies

Quality Assurance & Compliance

Quality Solution Design & Execution

Quality Training & Development

Continuous Process Improvement

MDSAP

Team Leadership & Collaboration

Supplier Management

Change Management

Performance Management

Professional Experience

Ventana Medical Systems Inc.

2011-2019

Quality Systems Auditor

A Member of The Roche Diagnostics Group

Manufacturer of Class I, II and III Instruments and assays for cancer diagnostics.

Selected to manage and improve the quality audit program for all Ventana sites. Rewrote Quality Manual for 13485:2016 and MDSAP. Lead audit planning, execution and reporting. Conduct all audits on time and ensure coverage of all applicable regulatory standards including; 21 CFR 50 series, 820, 806, 803, ISO 13485, SOR/98-282, 98/79/EC and MHLW Ord 169. Standardize audit findings against regulatory standards for data analysis to direct resources. Manage and improve the CAPA program. Former chair of the weekly CAPA Board. Follow-up on all audit findings / CAPA to insure resolution and effective closure. Conduct CAPA effectiveness verifications. Manage backroom for all FDA and notified body inspections / audits. Compose and report quality metrics.

Selected Achievements

Implemented Global audit metrics. Recruit and train audit resources. Develop auditor qualifications and training.

Improved all phases of the audit program; planning, execution and reporting by implementing an audit-planning checklist and by utilizing audit management software.

Improved all phases of the CAPA program, made Board meetings more interactive, motivated and mentored associates to engage in CAPA process. Trained all CAPA coordinators.

Glenside Enterprises

2010-2011

Self Employed

Purchase of a small business with spouse. Conduct due diligence, secure financing. Develop marketing and advertising materials, develop website, set up accounting.

Becton Dickinson

2007-2010

Supplier Quality Engineer

Pharmaceutical Systems Business Segment

Manufacturer of pharmaceutical delivery devices.

Selected to implement supplier quality program for North American and Mexican suppliers. Lead start-up activities supporting global sourcing strategy, quality standards, and compliance functions with accountability for setting up supplier metrics, supplier audit program, identifying and implementing continuous improvement activities and act as project leader for key supplier improvement initiatives. Improve customer relationships by addressing and reducing customer complaints attributed to supplier processes and products.

Selected Achievements

Implemented metal detection process at a key rubber supplier, thereby eliminating significant customer complaints.

Qualified new plastic injection molding supplier in Mexico, which represented a 28% cost improvement over previous supplier.

Reduced the number of critical suppliers by 10%.

2005-2007

Program Quality Manager

BD Preanalytical Systems Business Segment

Manufacturer of class I and II IVD’s.

Manage all aspects of the quality program for a molecular diagnostics joint venture as a virtual entity through continuous communications via Webinars, teleconferences and site visits to the German partner. Successfully led Quality and Regulatory functions at both entities regarding joint venture product. Served as corporate liaison to executive management of both partners. Served as sole legal entity between joint venture and all regulatory and licensing bodies.

Selected Achievements

Achieved ISO 13485 certification and initial product registration for joint venture products.

Insured all regulatory filings and complaint investigations for both EU and US were correct and on time.

Generated significant cost savings through the management review process by identifying areas of improvement and implementing corrective actions and continuous improvement activities.

Maximized quality performance by developing and implementing joint venture team meeting format and schedule, which insured the joint venture, was meeting customer requirements as well as all regulatory requirements.

Lead Quality Auditor

BD Preanalytical Systems Business Segment

2001 - 2005

Manufacturer of class I and II IVD’s.

Create and manage a highly effective audit program, encompassing internal, manufacturing sites, and suppliers. Schedule, plan, perform and close all audits including internal, supplier and manufacturing sites. Select and manage audit team, determine audit objectives and follow through on all audit findings / CAPA to satisfactory resolution. Collect, analyze and present audit and CAPA trends at Management Review. Recommend and implement strategies to address negative trends for audit, CAPA and complaints. Identify and deploy best practices within business unit. Conduct mock FDA inspections, facilitate actual FDA inspections.

Selected Achievements

Implemented auditor training program for entire global audit staff of 12 associates. Training consisted of RAB certification, product and process cross-training, and advanced auditor skills development. The training program improved audit effectiveness by providing a consistent audit format designed to facilitate continuous improvement.

Designed, wrote and deployed local CAPA system to manage publication, review, approval, distribution, and maintenance of all corrective actions generated within the business unit, improving productivity 100%.

Designed and deployed global problem / root cause analysis training for all associates tasked with CAPA response. Training improved CAPA response and effectiveness 100%. Conducted CAPA response training (investigation, RCA and validation/effectiveness verification) for non-quality associates.

Selected to represent Business Unit on CAPA council, tasked with selecting and implementing a Global CAPA process and software solution. Selected Trackwise for CAPA, audit and complaint management.

Worked jointly with Regulatory Compliance Manager to streamline and improve MDR/MDV and recall processes and procedures. Assisted in recall process.

Senior Quality Engineer

BD Consumer Healthcare Business Segment

2000 - 2001

Manufacturer of class I and II diabetes care products, braces and bandages, thermometers, and gloves.

Managed all quality requirements for assigned project teams for class I and class II medical devices. Review and approve product development plans, qualification and testing protocols, product release and incoming inspection levels. Lead multi-functional design FMEA's. Work closely with suppliers and manufacturing sites to resolve quality issues and implement continuous improvement activities.

Selected Achievements

Assisted in the implementation of the software quality function for a new product launch of a blood glucose monitor for both internal software and user software.

Key team member for initiation of global category management function, which significantly reduced procurement costs by consolidating and leveraging spends within key categories.

Goodrich Aerospace

Process Engineer

1994 - 1999

Designed manufacturing methods, and procedures for electronic control systems and electro-mechanical actuation systems for aerospace applications. Ensure that all quality and regulatory (FAA) requirements were achieved during manufacture and product release. Design and manufacture tooling and test equipment using Autocad to support qualification and production. Document entire fabrication process including; engineering drawings, test protocols and assembly work instructions. Release documentation through formal document control system, maintain configuration control and process change control.

Selected Achievements

Key team member for implementation of paperless work instruction initiative. Served as IT function liaison.

Designed and deployed a tooling and fixture database resulting in a 100% productivity improvement.

Senior Quality Engineer / Advanced Goodrich Aero Quality Systems Manager

1984 - 1994

Manage mechanical and electrical metrology/calibration functions; two FTE’s, 3 part time. Responsible all phases of quality assurance within a high-tech aerospace environment, including supplier quality, supplier process improvement, supplier audits and supplier corrective action. Ensured that quality systems met all customer requirements. Implemented specific requirements for major customers including; Boeing, McDonnell Douglas, Raytheon, GE, Sikorsky and Lockheed Martin. Provided quality input for entire product life cycle including: RFQ response, contract review, specification review, design review, supplier requirements, prototype, initial production, full rate production,, qualification test, acceptance test, failure analysis and corrective action, and configuration control.

Selected Achievements

Implemented advanced quality systems, software quality, and continuous improvement including authoring all procedures and work instructions. Company was recognized by key customers for having deployed advanced quality planning.

Implemented the use of mainframe computer information for users through the use of queries to obtain quality and supplier metrics resulting in a 100% productivity increase.

Pioneered the use of tangless helicoils on all production items, which significantly reduced inspection times and reduced customer complaints for FOD (foreign object damage).

Education / Certification / Affiliation

B.S. in Business Administration

Certified Quality Auditor (CQA)

Sr. Member, American Society for Quality (ASQ)

Six Sigma Green Belt certification

RAB Lead Auditor Certification (expired)

GDT Training

Root Cause Training

Risk/FMEA Training

Previously held Secret Clearance

Autocad

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