MOLEWYK, LLC, Grand Rapids, Michigan (2009-present)Molewyk, LLC is my independent consulting firm that specializes in applying Quality improvements through Lean/Six Sigma, Project Management and Concurrent Engineering methodologies in the bio/pharmaceutical and other industries, from product design to the factory floor. Independent Consultant• Performed corporate quality system assessments, led remediation of Investigation/CAPA system, and led team that created policy documents, high level SOPs, and User Requirement Specifications for electronic Quality Management Systems at a leading biotech company, as an independent consultant for Compliance Partners/PAREXEL International.• Executed consent decree baseline audits at facility that produces aseptically filled and lyophilized SVPs, as an independent consultant for Compliance Partners/PAREXEL International.• Conducted investigations, root cause analysis, and CAPA development/implementation for pharmaceutical site under consent decree that manufactures aseptically filled and lyophilized SVPs.• Benchmarked and performed gap analysis for Hollister International’s Design for Manufacturability and Assembly (DFMA) training program.

Towel Tracker, LLC is a second stage high tech company that was founded in 2009 and was named one of Michigan’s “50 Companies to Watch” in 2017. It manufactures the patented RFID-based Towel Tracker, which eliminates towel theft at hotels, resorts, and fitness clubs in 20 states plus Puerto Rico. Towel Trackers dispense pool towels embedded with washable RFID chips, which enables our customers to track towel usage and returns in real time, via cloud-based data analytics. Partner / Product Development and Customer Service Lead Early partner and one of the first employees in this company. Responsible for the following:Product development: Led product design team, using Design for Six Sigma tools; included building consensus for user and functional requirements, facilitating FMEA process, and writing/coordinating software testing protocols.Commercialization: Built from scratch the manufacturing supply chain and an operations system capable of producing and deploying thousands of Towel Trackers annually.Product deployment: Ensure Towel Trackers are efficiently shipped and installed at client locations throughout the contiguous United States, plus Hawaii and Puerto Rico; supervise field technicians who install them.Client software integration: Oversee all software integration and validation required to integrate customer locks/software systems with Towel Tracker. Completed 6 major customer integration efforts in 2017, which led to record sales in 1Q 2018.Customer service: Developed and lead team providing high level of customer service that led to zero returns in 2017.Quality: Write and perform software testing protocols; created product development policies and procedures that have significantly increased product reliability and reduced technical/help desk costs by 80%.

Supervised maintenance department (28 mechanics, 2 engineering technicians, and 2 exempt supervisors) responsible for servicing all production equipment used to manufacture and package injectable vials and ampules, 200 mL-500mL glass bottles, and 50-2000 mL filled IV bags. Areas serviced also included aseptic filling and lyophilization, as well as terminal sterilization filling and finishing operations.

Managed the Maintenance department (32 employees on three shifts) that serviced all production equipment used to manufacture and package 50 mL-2000mL filled IV bags

Production Supervisor (Abbott Laboratories;1999-2001)Supervised a two-shift operation of 37 total employees on four production lines, producing terminally sterilized emulsions in 5-500 mL glass containers, with an emphasis on productivity and quality improvement using Lean Six Sigma methodologies.

Member of the Hospital Products Division Technical Services Group, which helped internal clients identify and implement solutions to processes and packaging components used in manufacturing sterile pharmaceuticals and devices. Designed and assessed new or novel packaging, served as the manufacturing liaison on product development/launch teams, and designed/implemented cost reductions utilizing Lean Six Sigma methodologies.

Member of biological development pilot plant team that validated the facility and used mammalian cell culture to produce recombinant proteins, monoclonal antibodies, and vaccines that were used in clinical trials.

SVP Aseptic filling and component preparation supervisor.