Professional Profile
An experienced and accomplished Quality Engineering Manager and certified Six Sigma Master Black Belt with a talent for making complicated concepts understandable. Constantly on the lookout for ways to improve and how an organization can bridge the gap between the strategic and the tactical. Adept at developing, leading, and mentoring people and aligning their efforts toward common goals. Experienced and effective in the fast-paced and highly regulated medical device manufacturing environment.
Qualified, experienced and skilled Quality Leader.
Experience
November 2001 to Present
BD Diagnostics (Becton Dickinson) manufacturing facility in Broken Bow, NE
High volume manufacturer of medical devices for sample collection
o October 2007 to Present: Quality Engineering Manager
Regarding Quality: Identify strategic opportunities for improvement and growth at the manufacturing plant level in the service of greater regulatory compliance, product quality, and final cost. Often chosen to serve as plant and manufacturing representative on improvement efforts across the division and across the corporation. Play a central role in regulatory audits, both internal and external (ISO 13485, FDA, etc) as an auditor and auditee. Interface heavily with Quality Systems (change control, validation, CAPA, customer complaints, calibration, etc.) Expert in design control process, both as relates to process and product considerations. As leader of the in-process QA group, heavily involved with issue resolution and non-conforming product containment and disposition (MRB). Have experience in supplier management, both through the qualification and introduction of new materials/suppliers and past leadership of the incoming QA lab.
• Example: Served as core team member on a Corporate team to develop a toolkit for in-process sampling and reaction which was both based on sound statistical methodology and process understanding. This toolkit is now being deployed as a common methodology across the all manufacturing sites to ensure sampling is value-added and compliant.
Regarding Engineering: Drive the development and deployment of Six Sigma as a Master Black Belt. Have been trained in Design for Six Sigma and have taught Green Belt and White Belt classes, and mentored both formally and informally. Extensive experience with process and product development, validation and post-launch support and well versed in FMEA’s, DOE’s, MSA’s, SPC and statistical analysis including Minitab. Used Design for Six Sigma tools in support of new product development activities and ensuring manufacturing is considered during product design. Often called upon to lead root cause analysis into in-process issues of the highest magnitude.
• Example: Have taught Six Sigma Green Belt training several times, including the classroom sessions as well as supporting the teams as they execute their projects. Also sit on a Corporate team to evaluate Black Belt certification project submissions.
Regarding Manager: Have direct responsibility for six team members supporting plant quality engineering projects, including validations, cost savings, and in-process issue resolution. Also have indirect supervision responsibility for twelve other team members. Ensure that the team is equipped for the task at hand and properly allocated in service of plant and corporate goals.
• Example: Led the quality team in support of the installation and launch of a multi-million dollar manufacturing line consisting of over a dozen individual validations. Executed the most challenging validations while tracking and enabling the progress of the larger extended Quality team to ensure a successful and on-time launch.
o February 2003 to October 2007: Senior Quality Engineer (promoted from Quality Engineer in December 2006)
Led Black Belt project to solve a long-standing waste issue resulting in over one million dollars annual waste savings.
Spearheaded project to automate data collection of quality information to increase measurement accuracy, reduce operator interaction and provide better process feedback.
Often served as Quality Core Team Leader on major capital projects (machine design, debug, FAT, DOE’s, procedures, validation).
Extensive validation experience (product, process, molding, software) and root cause investigation expertise (FMEA, CE Matrix, fishbone, etc.)
Participated in and lead numerous Lean events, including those focused on productivity/waste, as well as using Turbo Six Sigma/Lean methodology in support of Black Belt projects.
Facilitated supplier incoming testing lab, interfacing with suppliers and vendors in qualification and issue resolution.
o November 2001 to February 2003: Chemistry Lab Analyst
Prepared solutions for addition to blood collection devices.
Performed analytical testing of prepared solutions and incoming materials.
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