Summary
Overview
Work History
Education
Skills
Professional Skills Training Certifications Awards
Certification
 Recipient of the CR Bard “Charlie” Quality Award for outstanding quality achievements in Covington
Timeline
WAYNE M. SANDBO

WAYNE M. SANDBO

Jefferson,USA

Summary

Experienced professional with a proven track record in designing, integrating, and upgrading quality systems, implementing robust design controls, and managing product life cycles from conception to commercialization. Over 28 years in the medical device industry with hands-on experience managing groups responsible for compliance with quality management systems (FDA, ISO 13485, 14971, 11135 and IEC 62304). Proven results in leading staff responsible for projects from conception through post launch; including design/process plans, design validation/customer preference evaluations, product design characterization, test method validation, design verification/validation, stability/shelf-life studies, risk analysis, process and product validations, design transfer/supplier management, and post launch surveillance. Experienced in Quality Operations leading groups responsible for Sterilization, Incoming Quality Control, Production, Kitting, and Rework. Recognized as an individual who can partner with individuals in both a direct and indirect reporting relationship. Management representative for outside authorities (i.e. FDA, Notified Body) to demonstrate regulatory compliance and product efficacy.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Associate Director – Global Process Owner, Risk Management/Stability & Shelf-life

Becton Dickinson (BD)
01.2020 - 10.2025
  • Provide strategic direction and oversight to ensure consistent global leadership for risk management, stability & shelf-life and design controls.
  • Lead a collaborative community of global SME’s comprised of Segments, Business Units, Regions and Functions to define, develop and implement policy, processes and procedures for global risk management, stability & shelf-life and design controls.
  • Responsible for monitoring internal and external regulatory observations and trends and implementing changes across the enterprise.
  • Serve as subject matter authority on risk management, stability & shelf-life and design controls.
  • Lead continuous process improvement projects and partner with SMEs on key initiatives.
  • Ensure consistent application of risk management activities across all elements of the Quality System (e.g. Complaints, CAPA, Field Actions, NC’s, Supplier, etc.).
  • Establish training requirements and orchestrate training for risk management, stability & shelf-life and design controls.
  • Monitor internal and external audit observations within BD, identify the appropriate cause and implement fixes across the enterprise for risk management, stability & shelf-life and design controls.
  • Partner with standards committee to monitor for external regulatory changes and determine the need for changes to policy, procedure and practices based on regulatory changes and implement where appropriate.

Senior Manager QA, Sterilization Assurance (CR Bard and BD Medical)

Becton Dickinson (BD) and CR Bard Medical
01.2016 - 01.2020
  • Managed all aspects of the quality operations, including staff and quality system for multiple ETO Sterilization plants including operations for Incoming Quality Control, Production, Kitting and Rework.
  • Ensured compliance with divisional, corporate, FDA, ISO and EN requirements and maintained all sterilization QA related procedures.
  • Led the development of strategic initiatives related to BD Sterilization Operations.
  • Led Regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits.
  • Managed product on-loads into Interventional Sterilization for divisional project teams and coordinated testing for adoptions.
  • Supported sterilization validation and cycle development.
  • Oversaw updates of specification sheets and final approvals.
  • Managed improvement projects, sterilization CAPA program, and MRR/non-conformances process, and sterility risk management program.
  • Led supplier and internal audits related to Sterilization Operations and oversaw supplier changes and supplier corrective actions.

Manager, Quality Engineering

Bard Medical
01.2010 - 01.2016
  • Strategic business partner for Home Health, Critical Care, Pelvic Health, Endourology, and Brachytherapy Franchises providing Subject Matter Expertise on a wide range of products and processes.
  • Managed and coached Quality staff responsible for new product and sustaining engineering projects which included defining, leading, and implementing quality engineering in the design and development of products, and in transfer and steady state phases of manufacturing operations.
  • Partnered with R&D, Marketing, Purchasing, Regulatory, and Operations Management regarding product and supplier quality.
  • Directed activities for both domestic and international suppliers with a focus on cost savings and proactively/reactively addressing part or product issues.
  • Interim Quality Plant Manager on multiple occasions for the BD Brachytherapy manufacturing plant.

Senior Quality Engineer

Bard Urological and Medical
01.2006 - 01.2010
  • Responsible for driving compliance to design controls for both product and process changes.
  • Created quality plans to achieve compliance while meeting business objectives.
  • Managed the validation strategy for both new product development and sustaining engineering.
  • Drove risk management process (Hazards Analysis, AFMEA, DFMEA and PFMEA activities) to ensure compliance to ISO 14971.
  • Prepared and implemented quality system documents.
  • Led activities with outside authorities (i.e. FDA, Notified Body) to demonstrate regulatory compliance and product efficacy.
  • Supported the internal audit and Supplier Quality System audit programs, including vendor selection and initial/ongoing vendor qualifications, design history file audits, and data integrity audits.
  • Analyzed process and product non-conformances and implemented comprehensive corrective and preventive action plans (i.e. DMAIC Failure Investigations).
  • Provided technical support for complaint investigations. Worked closely with cross-functional teams to determine root cause and implement action plans.
  • Developed quality indicators for new product launches and responsible for conducting post launch and post market surveillance activities.
  • Supported 510(k) submission process by providing input and conducting pre-submission reviews.
  • Managed and mentored engineers supporting various product lines and projects across the business.

Quality Engineer III

Bard Urological Division
01.2005 - 01.2006
  • Quality team member for both new product and sustaining engineering projects, ensuring compliance to procedures, standards and regulations.
  • Managed multiple projects while maintaining functional responsibilities including supplier and internal audits, complaint evaluations and trending, incoming quality non-conformances and acting as an independent QA reviewer for design reviews.
  • Responsible for conducting design, process, and product validations.
  • Performed statistical analysis and served as the statistical resource for project teams.
  • Drove the creation and execution test method validation.
  • Conducted failure investigations and implemented corrective and preventive action plans.

Quality Engineer II

Mills Biopharmaceuticals, Inc. (Brachytherapy Division)
01.2003 - 01.2005
  • Project manager over systems involving manufacturing Quality Assurance, process monitoring, process and equipment validation, internal and external audits, complaint handling, medical device/vigilance reporting, corrective/preventive actions, document control, supplier quality, risk management, and new product development.
  • Provided technical and managerial leadership in assuring compliance with 21 CFR Part 820, ISO 13485, ISO 14971, Canadian Medical Device Regulations, and Medical Device Directive 93/42/EEC.
  • Interacted with outside authorities (i.e. FDA, Notified Body) to demonstrate regulatory compliance, and product efficacy.
  • Responsibilities included: creating, reviewing, and approval of documentation for quality system, product literature, incoming inspection, supplier management, and operation/manufacturing activities.
  • Responsible for assuring quality measures were in place to assure continuous manufacturing improvement and quality system achievement.
  • Proactive in problem solving and, in the identification, and implementation of new system methods and practices that affected process and product optimization, to improve efficiency and reduce costs.
  • Managed the internal and external audit programs and management of 5 internal auditors: including vendor selection and initial/ongoing qualifications.

Quality Assurance Engineer I

Smith & Nephew Inc. (Endoscopy Division)
01.2000 - 01.2003
  • Oversight of the document control department, which included development and maintenance of internal policies and procedures for continuous improvement to the Quality System.
  • Assured compliance with 21 CFR Part 820, ISO 9001, ISO 13485, Canada Medical Device Regulations, and Medical Device Directive 93/42/EEC.
  • Interacted with outside authorities (i.e. FDA, Notified Body) to demonstrate regulatory compliance and product efficacy.
  • Served as the Audit Administrator, which included coordination of the internal and external audit programs and oversight of 17 internal auditors.
  • Developed and approved process and equipment validation activities for manufacturing processes for internal and external suppliers.
  • Participated in teams for failure investigations, corrective/preventive actions, and risk management.
  • Ensured product complaints were processed with full analysis and failure investigations, including Medical Device and Vigilance Reporting.
  • Reviewed and approved product changes for quality system impact.
  • Responsible for tracking and trending of Quality indicators and reporting results to management.

Associate Quality Assurance Engineer

Smith & Nephew Inc. (Endoscopy Division)
01.1997 - 01.2000

Education

Bachelor of Science - Business Administration – Organizational Leadership

Southern Nazarene University, Bethany, Oklahoma

Skills

  • Project Management
  • Quality Systems/Operations
  • Risk Management
  • Validation
  • ETO Sterilization
  • Leadership/Compliance
  • Design Controls
  • Design Transfers/Manufacturing
  • Auditing
  • Failure Modes Effects and Analysis
  • Process Validation
  • Geometric Dimensioning & Tolerancing
  • Effective Project Management
  • Process Mapping
  • Root Cause Investigation for Corrective and Preventive Action
  • Managing the Development Process
  • Team Leadership
  • Creative Problem Solving
  • Risk Mitigation
  • Business Process Infrastructure
  • Process Validation/Verification
  • Quality Achievements

Professional Skills Training Certifications Awards

  • American Society for Quality: Certified Quality Auditor (CQA)
  • American Society for Quality: Certified Quality Engineer (CQE)
  • American Society for Quality: Failure Modes Effects and Analysis
  • Association for the Advancement of Medical Instrumentation: Design Controls
  • Association for the Advancement of Medical Instrumentation: Risk Management
  • Association for the Advancement of Medical Instrumentation: Process Validation
  • AGI: Certified in Geometric Dimensioning & Tolerancing
  • Rockhurst University: Effective Project Management
  • Worchester Polytechnic Institute: Process Mapping
  • Software: JDE, SAP, Master Control, StatGraphics, Trackwise and Microsoft Office
  • The Center for Professional Advancement: Root Cause Investigation for Corrective and Preventive Action
  • Roy Associates - Project Leadership: Managing the Development Process, Team Leadership, Creative Problem Solving, and Risk Mitigation
  • Arizona State University - Institution for Configuration Management: Project Management, Business Process Infrastructure, and Process Validation/Verification
  • Recipient of the CR Bard “Charlie” Quality Award for outstanding quality achievements in Covington Georgia (Sterilization)

Certification

American Society for Quality: Certified Quality Auditor (CQA)

American Society for Quality: Certified Quality Engineer (CQE)

 Recipient of the CR Bard “Charlie” Quality Award for outstanding quality achievements in Covington

Received for outstanding quality achievements in Covington Georgia (Sterilization)

Timeline

Associate Director – Global Process Owner, Risk Management/Stability & Shelf-life - Becton Dickinson (BD)
01.2020 - 10.2025
Senior Manager QA, Sterilization Assurance (CR Bard and BD Medical) - Becton Dickinson (BD) and CR Bard Medical
01.2016 - 01.2020
Manager, Quality Engineering - Bard Medical
01.2010 - 01.2016
Senior Quality Engineer - Bard Urological and Medical
01.2006 - 01.2010
Quality Engineer III - Bard Urological Division
01.2005 - 01.2006
Quality Engineer II - Mills Biopharmaceuticals, Inc. (Brachytherapy Division)
01.2003 - 01.2005
Quality Assurance Engineer I - Smith & Nephew Inc. (Endoscopy Division)
01.2000 - 01.2003
Associate Quality Assurance Engineer - Smith & Nephew Inc. (Endoscopy Division)
01.1997 - 01.2000
Southern Nazarene University - Bachelor of Science, Business Administration – Organizational Leadership

Similar Profiles

CREATE PROFILE