• Michigan Public Service Commission (MPSC) Rule Owner and Report Filer. Information Sharing Compliance Assurance Manager.• Identifies/monitors government reporting requirements and developed/implemented/updated an approved/documented process to collect information/data, compile report, seek stakeholder approval, and submit annual reports to ensuring compliance with government reporting policies while meeting regulatory agency deadlines. • Collaborates with legal and stakeholders using released process that I developed to compile and submit regulatory filing. Most recent submission resulted in first time pass approval by all stakeholders and was ready to submit to regulatory agency 2 weeks ahead of schedule.• Responsible for tracking, reporting, retention, and sharing customer information shared by utility to unregulated program. • Collaborates cross functionally to support unregulated business transition by providing solutions to ensure compliance to regulatory requirements/business agreements and to prevent unnecessary information sharing.

• Built/Lead Quality System and Compliance Team (4 direct reports) and 4 technical writers.• Developed regulatory compliance strategy and program from scratch to include regulatory monitoring/intake, regulatory compliance metrics, and noncompliance reporting processes resulting in over 50% improvement in compliance maturity in the first year. • Regulatory Compliance Accountable Authority (AA)/Compliance Assurance Manager responsible for working with other AAs, Legal, and other internal/external stakeholders to identify, document, communicate, and apply regulatory compliance requirements to the organization to ensure compliance to internal company requirements/applicable laws/regulations. • Created Quality Management System (QMS) from scratch based on ISO 9001:2015, developed implementation plan, and trained organization of close to 250 employees from multiple departments.• QMS software Project Manager and Administrator/Designer, responsible for defining requirements, configuration, implementation, and maintenance of EtQ Reliance. • Established, implemented, and maintained policies, plans, standard operating procedures, work instructions, forms, templates, and logs for change management, document control, training, risk management, regulatory compliance, noncompliance reporting, audits, management responsibility, and government reporting.• Collaborated with business and AAs to compile corporate risk map and communicates results to senior leaders.• Developed and implemented management review process and leads/conducts management reviews with business leadership.• Audit Representative responsible for working directly with auditors to develop audit scope/schedules, facilitating audit interviews, finalizing/negotiating audit findings/reports, managing audit action item development from creation through closure, and reporting status to Internal Controls. Proactively developed and implemented internal audit process.

Collegiate Stunt the Sport-Routine Official, Scoring Official, and Referee

Panel and Safety Competitive Cheerleading Official

NAIA Competitive Cheeleading Official

Led/mentored Quality Department with 2 direct reports. Created/updated/implemented/maintained quality management system (QMS) content for compliance to FDA 21 CFR / ISO 13485 and ensure proper stakeholder alignment.• Managed/Maintained the following processes: document control, nonconformance management, internal audit, customer complaints, training/competence, supplier controls, regulatory standard monitoring/maintenance, and corrective action preventive action (CAPA).• Performed gap analysis and created regulatory strategic plan for achieving ISO 13485 Certification.• Prepared/Submitted Investigational Device Exemption (IDE) annual/semi-annual regulatory filings to the FDA (with first time acceptance). • Led and conducted periodic internal quality system audits and management reviews.• Reviewed/Approved clinical monitoring reports, product development documentation, control plan updates, and maintained design/device history files/records.

Oversaw production process, monitored quality standards of products, and implemented quality control and tracking programs to meet quality objectives.• Created/updated complaints and return material authorization (RMA) processes / procedures / forms for compliance to ISO standards. Remediated current and past complaints and RMA records to ensure 100% compliance to new procedures.• Managed human and material resources to meet production targets and timelines and ensured a 100% on time delivery.

Built/Led/Mentored 10-person Quality and Regulatory Department responsible for regulatory, quality management system (QMS), supplier quality, production quality, design quality, post market surveillance/customer complaints, document / record control, field service, training, and customer support activities in promotion, sale, distribution, and field service of unclassified, Class 1, 2, and 3 Medical Devices.• Developed and executed regulatory strategy for new 2 new medical devices. • Led cross functional team in creation of QMS to include items such as Quality Manual, Quality Policy, procedures, and associated documents, to market, sell and install medical devices in less than 8 months while ensuring all activities had proper stakeholder approval and were conducted in compliance with relevant laws, regulations, and guidance documents.• Developed training/communicated regulatory requirements to team.• Assisted sister company with product development of new products for compliance to FDA and International Standards, with creation of a QMS, and with regulatory filing submissions resulting in a first pass ISO 13485 certification and successful transfer of manufacturing to contract manufacturer.

Quality team leader in remediation / day to day activities to include design/technical reviews, risk reviews, study designs, test method validations, change management, process validations (IQ, OQ, PQ), design/process, risk management/ Failure Mode Effects Analysis (FMEA), equipment suitability requests, calibration requests/failure investigations, health hazard evaluations, product recall activities, corrective action preventive action (CAPA), and identification, segregation, and evaluation of nonconforming product.• Updated and implemented companywide Nonconformance Management Process, resulting in closure of 134 audit findings.• Quality team lead for sterile product line and in creation/implementation of non-conforming product segregation process in a Class 8 controlled environment.• Led cross functional CAPA team in identifying the potential root cause(s) in less than 5 days for a product nonconformance which prevented shipment of several product lines. Led development/validation of a test method to identify nonconformance, which improved inspection of product and allowed products unaffected by the root cause to be released from hold.

Led/Mentored 9 direct reports in the design, development/specification, fabrication/purchase, installation, qualification, calibration, and preventive maintenance of equipment/tooling/fixtures, in resolution of production assembly/machining issues, in continuous improvement projects, in the update of design/product documentation, in review/approval of control plans, and in updates to/creation of risk management/Process Failure Mode and Effects Analysis (PFMEA) documentation.• Used Six Sigma methodology (DMAIC) as corrective action preventive action (CAPA) leader of cross functional team for 3 high profile CAPAs for a Class 3 (Life Sustaining) Medical Device, one of which was to address the company’s #1 customer complaint, resulting in establishment / implementation of torque requirements in less than 3 months and in software design changes to allow for a quick restart of the product if jammed.• Evaluated production workflow and worked cross functionally with corporate Engineering Lead and production personnel to updated manufacturing work instructions with improved standard work format, resulting in improved efficiency, reduction of non-conforming product, and adoption of a new companywide production work instruction format. • Participated as the Manufacturing Engineering Representative in New Product Development activities to include review of User Needs/ Design Inputs/Design Outputs/Verification and Validation Activities to ensure new products were designed for manufacturing (DFM).

Led/Mentored 5-person Product Engineering, Regulatory, and Laboratory Testing Team in product design/testing of cost effective, manufacturable, and compliant thermoplastic, thermoplastic elastomer, and thermoset wire products. • Led regulatory planning, executed regulatory strategy, engaged with regulatory agencies, and influenced industry policymaking to advocate the voice of the customer (VOC) and to ensure compliance of various current and future product lines. • Collaborated with internal cross functional teams and externally with customers, suppliers, and regulatory agencies (ASTM, UL, SAE, CSA). • Process owner / developer for the following processes: regulatory, new product development, engineering change management, design review, prototype/sample run, and product testing. • Improved engineering change completion rate by 80% by designing, implementing, and training the company in the use of electronic change system. • Developed standard operating procedures, training, and follow-up audits for creation/maintenance of product records resulting in an improvement in accuracy of 98% within 6 months of implementation.

Collaborated with Release/Manufacturing Engineers on Army/Marine Transparent Armored Guns Systems for various military vehicle configurations. • Evaluated the impact of design/specification changes on current part release to ensure compliance to customer contract. • Developed a tracking system to track production progress and coordinate part shipment to three different assembly facilities to ensure 100% on time delivery of assembled kits to the customer.

Team leader in creation/release of vehicle frame designs/documentation for Isuzu, General Motors, and Toyota truck/SUV Programs.• Led collaboration of internal and external cross functional teams from concept through production (including design, prototype, product reliability testing, line debug, accuracy gain, and production part approval process (PPAP)).• Experienced in incorporating the voice of the customer (VOC), Design for Manufacturing (DFM), risk management/Failure Mode Effects Analysis (FMEA), error proofing, statistical process control (SPC), Kaizen/continuous improvement, use of quality management system, and in manufacturing of heavy metal stampings, welding, post piercing, self-piercing/clinch nut application, bushing insertion, and e-coat application. • Developed over $500,000 in cost saving in Value Added Value Engineering Efforts (VA/VE) (Waste Reduction/Continuous Improvement)• Led new plant in achieving Customer PPAP on 1st submittal, allowing product manufacturing to start without delay.

Managed the 56th EOD’s Nuclear/Biological/Chemical and Administrative Departments and 2 direct reports.• Held a Top-Secret clearance / Received Honorable Discharge. • Wrote/Maintained Standard Operating Procedures to comply with current United States Department of Defense military standards (MIL). • Identified conventional / improvised explosive devices, determined their hazards and safety/exclusion areas, and destroyed/rendered safe.• Collaborated/Supported local law enforcement agencies (Alcohol Tobacco and Firearms (ATF), Secret Service, and Department of State) in searching for explosive devices, for personnel such as the President, First Lady, Vice President, and foreign dignitaries.• Responsible for inventory, maintenance, and calibration of nuclear, biological, and chemical equipment.