Doug Weitzel

Sr. Engineer                                                                             

Doug has a diverse knowledge of quality processes and procedures in the medical diagnostics industry. He possess excellent interpersonal skills that enable me to effectively maintain dialogues between various groups; including groups within an organization and outside, regulatory agencies (FDA, ISO, CBER, CDRH). In addition, I possess Quality Auditing experience as well as training in statistical methods and knowledge of the ISO standards. I excel at defining and evaluating problems to ensure a timely resolution.  

EXPERIENCE ...  

• Instrumental in developing company wide validation policy, developed Master Validation Plan, and managed validation implementation project for medical diagnostics manufacturer.
• Managed validation project for new diagnostic assay, assisted with the writing of an Assay Validation Master Plan. Hands-on protocol development and execution test method validations, process validations, and equipment qualifications to support project.
• Managed and provide hands-on support for numerous qualification activities including equipment qualifications, cleaning validation, and software qualifications.
• Created Master Validation Plans for Equipment; maintained Validation Library; ensured production, quality assurance, qualifications processes and GMP issues were within regulatory guidelines; primary contact for external regulatory and internal quality groups; provided training and technical support within the organization on qualification issues.
• Responsible for quality assurance for final product releases, interfaced with CBER for lot releases of product, performed product lot analysis of new product feasibility, developed inspection criteria, performed compliant analysis and evaluation.
• Assisted with regulatory inspections, reviewed and approved validation protocols and final reports, reviewed and approved corrective actions and change requests.
• Increased production from 90,000 units per week to 400,000 units per week, while reducing cost of unit by half; initiated World Class teams centered around equipment; essential in development of Automatic Assembly process; instituted weekly meetings for training and educating employees; responsible for scheduling R&D runs and coordinating equipment modifications; managed 40 employees on 3 shifts.
• Directed installation, set up and maintenance of industrial robots and vacuum material loading system.
• Initiated company wide preventative maintenance program, Rresponsible for maintenance of electrical, mechanical, and hydraulic equipment.
• Performed company wide Statistical Process Control Training.
• Supervised all quality, mold operations, and maintenance, evaluated prototypes; acted as customer liaison; monitored and controlled all inventories.

• Sr. Engineer                                                                                             BioTeknica
• Process Validation Manager                                                                    Abbott
• Validation Manager                                                                                  Abbott
• Qualification Manager                                                                              Abbott
• Quality Manager                                                                                       Abbott
• Production Supervisor, Assembly Operations and Fill/Label                   Abbott
• Maintenance Engineer                                                                              Superior Molding
• Plant Engineer                                                                                          Rehrig Pacific Company

• Mechanical Engineering Cornell University
• B.A. Physics Ithaca College