Quality Assurance Manager, Energy Storage Solutions - M.A. MORTENSON - Minneapolis, Minnesota (Remote in Iowa)
(2025-01)
Managing QA projects and assessments in the construction phases for Energy Storage Sites.
- Conduct training and assessments on construction sites
- Hazard Recognition (Haz Rec) and site safety training
- Kaizen events hosted on Battery Energy Storage Sites (BESS)
- Working directly with project managers, development phase engineers, electrical engineers, site engineers and technicians. Craft and non-craft including Union and Non-Union employees
- Collaboration with teams to understand the 3-phase quality process
- Oversite of battery energy storage site Quality Assurance and Quality Control activities
- Process and procedure development
- Developed and deployed calibration program for torque wrenches, meggers, survey equipment and crimpers
- Coaching site Engineers on Quality Processes, documentation and reporting non-conformances
- Conduct Quality and Safety Assessments
- Document Quality Alerts
- Hazard Recognition Audits
- KPI tracking and reporting
Quality Specialist II / Quality Engineer - ENEL GREEN POWER NORTH AMERICA - Andover, Massachusetts (Remote in Iowa)
(2022-01 - 2025-01)
Leading QA activities for North America Quality Assurance in O&M within the HSEQ Quality Team.
- Developed Project Quality Plans (PQPs) for Major Correctives and worked with contractors to develop Quality Control Plans (QCPs) in O&M
- Developed documentation for key processes for North America
- Delivered training and coaching on the North America processes and procedures as well as from Global Governance
- ISO Internal Lead Auditor for site and process audits
- Conducted training on Integrated Management Systems (IMS) requirements and ISO requirements across
- Coached and mentored Site Management on quality principles and the relevance to site activities
- Conducted audits of the Document Management System Integration Project
- Tracked and reported KPI's to Global Governance related to Major Correctives across wind and solar
- Quality management and interface with contractors for significant warranty claims globally
Quality Program Manager / PM Quality Assurance Manager - NORDEX USA, INC. - West Branch, Iowa
(2017-01 - 2022-01)
Management and oversight of process improvements, documentation of processes and procedures, and compliance auditing for the Project Management Division of Nordex USA for both Windfarm Quality and Project Quality. Recognized for leadership and contributions both Internationally by Spanish and German colleagues and across the North America Platform.
- Developed and deployed QA monthly training across the organization
- Led the PM QA Process Audit Team, coached and mentored auditors
- Led Internal ISO Requirements and Internal Process audits, on sites and in facilities
- Assisted with ISO Registrar, (Bureau Veritas), and customer audits
- Reviewed and revised documentation for numerous aspects of the North America PM Department
- Coached employees on utilization of current Nordex Systems; QuIS, ServiceNow, SharePoint, and EHS Insight
- Management of Deviation Request Process for PM. Documented Opportunities for Improvement (OFI) and implemented approved OFI's and lessons learned
Global Quality Affairs Manager - RR DONNELLEY & SONS, INC. - Iowa City, Iowa
(2015-05 - 2017-10)
Manager of Global Quality Affairs compliance to ISO 9001:2008 and transition lead for ISO 9001:2015. Responsible for metrics calculations, trend analysis, coaching, auditor certification, and leading transition team for the September 18, 2018, deadline of conversion to ISO 9001:2015 both in the United States and International Divisions.
- Developed and delivered training on fundamental QA principles; CAPA, RCA, Lean, Continual Improvement (CI), and Internal Auditing
- FDA and cGMP compliance for sites with regulatory compliance requirements
- Developed and revised standard operating procedures, flow diagrams, work instructions, and forms
Director of ISO Compliance and Continual Improvement for RR Donnelley Forms & Labels Platform North America and Quality Assurance Manager Iowa City Forms Manufa - RR DONNELLEY & SONS, INC. - Iowa City, Iowa
(2012-01 - 2015-04)
The platform consisted of 16 manufacturing facilities, producing pressure seal forms, 50" roll forms, labels, adhesive coating, and coated substrates.
- Provided guidance and coaching for cGMP and FDA compliant label producing facilities across the Platform
- Safety and Ergonomics ownership for Iowa City Facility include LOTO, Confined Space, Contractor Safety
- Responsible for daily production quality and customer complaint resolutions for the Iowa City Forms Plant
- Management Representative for the Central Office, (the governing body), for the Platform and ISO Registrar Host
- Led internal audit program across 16 facilities in accordance with IAF MD 1:2007 requirements
- Training for manufacturing site personnel on RCA, CAPA, problem solving, Kaizen, and Lean
Quality Assurance and Safety Manager - IMPACT FULFILLMENT SERVICES, Inc. - Iowa City, Iowa
(2011-01 - 2012-01)
Responsible for all aspects of QA and safety compliance for the Iowa City customization and manipulation facility. FDA and P&G Key Element Audit host. Document control for the site implementation and training on current, revised, and new standard operating procedures, (SOP's). Leadership of Self Improvement Program (SIP) and Trainer for Audit Team
- Prepared the facility for an announced FDA Audit. First FDA audit for the facility. This occurred 30 days after I joined the organization. No audit findings were issued
- Increased Procter & Gamble QA Capability audit score 56.5%, (31% QAC in 2011 prior to my hire). Site received a score of 87.5% in September 2012. First customization and manipulation site in NA to receive this score
- Re-wrote all company SOP's to be compliant with ISO 13485-2003 and ISO 9001-2008
- Process Improvement and internal audit trainer and in North Carolina and Iowa; RCA, CAPA, audit fundamentals
- Tracked and reported Key Process Indicators (KPI's) to P&G daily
- Implementation of cGMP and safety audits and implemented a go/no go classification of defects using visual aids
Quality Assurance Manager - LIL' DRUG STORE PRODUCTS, INC. - Cedar Rapids, Iowa
(2009-01 - 2011-01)
Pharmaceutical, Medical Device, and OTC manufacturing and distribution in 37 countries. Diverse product line ranging from feminine hygiene products, medical devices, OTC medications to automotive accessories, and paper goods. Responsible for QA functions supporting 3 Divisions; Consumer Products, Convenience Products and International Markets.
- Conducted supplier GMP and ISO compliance audits, delivered GMP training internally and to supplier contract locations, managed CAPA process improvement, investigated consumer complaints, managed change control process
- Responsible for development and training for standard operating procedures, database, and documentation control
- ISO Registrar, FDA/DEA point of contact
- Reduced ISO audit non-conformances from 5 majors, 15 minor non-conformances, and 14 OFI's in 2009 audit (prior to hire), dramatically down to 0 majors, 1 minor non-conformance and 2 OFI's in 2011
- Conducted ISO and GMP audits internationally, (Canada, Israel) and US, leading to process improvements
Quality Assurance Manager - PLASTIC PRODUCTS COMPANY, INC. - West Branch, Iowa
(2008-01 - 2009-01)
Responsible for QA in a 3-shift custom injection molding operation. Management of 12 QC technicians and 6 team leaders.
- Reduced Defective Parts Per Million (DPPM) from 2900 down to 212 within the first three months
- Redesigned workflow on the production floor that increased throughput efficiencies by 25%
Training and Development Manager - SCHENKER LOGISTICS INC. - West Branch, Iowa
(2006-01 - 2008-01)
Responsible for design, development and delivery of training that covered new hires, site safety and cGMP's for 700 employees. Duties also included Human Resource functions of recruiting, benefits training, and OSHA reporting.
- Implemented a video communications board in all break rooms and cafeteria
- Trained QA Team to be effective internal auditors, reducing the number of NC's identified by Procter & Gamble
Process Leader - ORAL-B LABORATORIES - Iowa City, Iowa
(2003-01 - 2006-01)
