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Director of Quality

Crystal Lake, IL
September 06, 2019

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312-***-**** Crystal Lake, IL Dear Hiring Manager:

I’m an experienced Global Leader with a demonstrated ability to successfully develop and lead operations & quality management systems. I bring a passion for continuous improvement by building and strengthening client relationships, mentoring high performance teams, and building / optimizing management systems to achieve business results.

I have a balanced management style of being collaborative, decisive and analytical in finding creative solutions and growth plans which have enabled me to consistently deliver strategic outcomes, improved customer satisfaction, save costs while building and enhancing teams. Please review examples from my enclosed resume, which highlight my ability to develop / improve Management Systems:

• Extensive Experience: (Medical Device, Food / Food Safety, Aseptic Processes, Beverage, Consumer Products, Over the Counter, Chemicals, Plastics, Extrusion, Blow Molding, Injection Molding, Milling, Liquid / Powder Fill)

• Support market growth by developing strategic plans and streamlined processes.

• Effective development, implementation & leadership of Global Management Systems: (Stage-Gate Program, Audit Program, HACCP, Lean Six Sigma, Regulatory Assessment & Risk Analysis, Supplier /Contract Management, 8D /Deviation / CAPA / FMEA, DMAIC, Cross- Functional Leadership)

• Negotiate strategic partnerships with suppliers and 3 rd

party stakeholders.

• Manage risk by preparing teams to navigate successfully through audit and response processes and create new self-sustaining programs for adherence to industry-best practices ongoing.

• Lead Auditor / Regulatory Compliance – Food Safe & ISO Lead Auditor Certification (Interface Directly with FDA, TUV, & other Regulatory Authorities) I am excited to learn more about this position and realize this letter and my resume cannot possibly convey all that I would expect to bring to your company. I would welcome the opportunity to meet with you at your convenience to discuss my candidacy. In the interim, I sincerely thank you for reviewing this letter and my resume.


Jacqueline Putman



312-***-**** Crystal Lake, IL Professional Summary

Global Quality Leader with expertise in manufacturing processes, quality management systems, product development, supplier management, cross-functional team leadership and delivering positive outcomes with strong sustainable gains. Able to identify and implement strategies to reduce costs, mitigate risks, increase revenue, strengthen customer relationships, improve business practices and drive profitable growth. Broad-based management skills, with strong planning, communication, organizational and decision-making ability to successfully direct concurrent projects. Mentors staff and encourages a team environment for high levels of employee confidence and satisfaction. Core Strengths & Skills

Process Improvement:

Lean Six Sigma Green Belt & Black Belt Training


Strategic Analysis, Cross-Functional Teams and Project Management

Lead Auditor:

• ISO 13485 - CMDCAS-CMDR - Medical Device Lead

Auditor Certification

• ISO 9001 Lead Auditor Certification

• GMA (FPA) Food Safe Certified Lead Auditor

20+ years Manufacturing & QSM Development: Medical, Food

& Beverage, Aseptic Mfg., Packaging, Consumer, OTC, Extrusion, Blow Molding, Injection Molding, Chemicals, Milling, Liquid, Powders

HAACP Certified - NSF CRM/ SAP – Vendor Management Applied Sensory Science & Consumer Testing Certificate – UC Davis

Regulatory Lead: FDA, Internal / External Audits - 21 CFR 820, 821, 822 (2019 – achieved no finding MDSAP certification) PROFESSIONAL EXPERIENCE

MEDELA LLC November 2018 to August 2019

Quality Director, of North America

• Led North American Quality / Quality Engineering team of 30 and held responsibility to serve on the Global Leadership team. (Role restructured to combine Regulatory & Quality roles and report to Switzerland thereby eliminating my position)

• Proactively held responsibility to streamline business processes through use of Lean tools and interfaced with global counterparts, senior management, executive committee and advisory boards to deliver innovative and transformational quality strategies, CI strategy and decision-making for alignment of the global regulatory and operations business initiatives.

o 600K in cost savings from streamlined inventory processes and harmonization of global processes o Led SAP Quality goals implementation ahead of schedule and identified a new global electronic management system.

o Implemented KPI scorecard and weekly management meetings to track Operational & Quality business objectives which led to 72% improvement of timely execution and closure of Deviation / CAPA & Risk Mitigation processes. Addressed backlogged adverse event assessments and reduced complaints by 30%.

o Directed the development and implementation of the Medela Quality Systems and programs to ensure compliance and inspection readiness with applicable regulatory standards and company policies, including FDA QSR, ISO 13485:2016, CMDR, CFRs, and cGMPs, including 21 CFR Part 820, ISO 13485, ISO 9001 and ISO 14971 standards

Achieved US MDSAP certification with zero findings (ISO 13485) and was onsite to support partners in Switzerland to achieve Global certification. o Reviewed and approved procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, product specifications, and supplier Issues. J A C Q U E L I N E P U T M A N

312-***-**** Crystal Lake, IL WESTROCK – Multi Packaging Solutions January 2017 – November 2018 Vice President of Quality for North America

• Led, directed, evaluated and developed quality assurance and regulatory compliance programs for 26 pharmaceutical and food industry sites within the region (US & Mexico) with a direct report at each site to ensure efficient and consistent implementation of the corporate, business unit and business area quality / operational strategy, according to established guidelines / regulatory standards, budgets and timeframes with 80% travel.

• Led monthly customer KPI meetings and high-risk customer investigations as required to ensure business goals were met or exceeded.

• Led and approved design and validation (IQ, OQ, PQ) activities for newly designed and manufactured products.

• Established and led the implementation of criteria & actions steps for high priority projects pertaining to product development, customer complaints, regulatory requirements and operating systems to ensure business success operationally. (Focused on quality disciplines creating a model for continuous improvement and reducing customer complaint rates by 50% annually.)

HONEY CAN DO INC. January 2016 – January 2017

Director of Quality Assurance

Managed US and Asia team to develop manufacturing control plans for all critical and at-risk processes to increase efficiency and reduce quality complaints. (Traveled to China every 4 weeks for onsite audits, to manage team and to partner / improve operational processes at contracted sites.)

• Developed a scorecard and an audit program for Asia manufacturing and hired a US Quality team for a new test laboratory.

o Developed and led company-wide ISO 9001 readiness program, stage-gate process for new products, LEAN training and Improvements which eliminated non-value-added testing, reduced inventory by 50% and implemented cost-efficient cross-training for a cost savings of $250K. o Recouped $550K+ in shipping errors and led strategic initiatives to reduce 50% of on time delivery issues LANDAUER, INC. November 2013 – November 2015

Director of Continuous Improvement and Quality Assurance

• Launched companywide Risk Management Program to mitigate and monitor operational and strategic risk that led to streamlined processes and LEAN Six Sigma project implementation 1.5K cost savings.

• Led internal audit teams and managed regulatory audits / customer audits and associated documentation for ISO 9001

/ 17025 / 13485 / NVLAP / Department of Energy

• Asked to lead as Director of Customer Service (Team of 35) in addition to Quality Director (team of 10) for 9 months to develop synergies between the quality and customer experience processes prior to the company hiring a CS Director.

• Promoted to Director of Continuous Improvement to oversee a $.5M capital budget and 15+ member Quality Assurance team across 8 on and offshore locations. METHOD HOME, INC. March 2008 – November 2013

Director of Quality

Managed Quality and compliance standards for 25 suppliers and 20+ contract-manufacturing facilities with team of five.

• Designed new Quality Management Programs for growing organization during company merger, major SAP conversion and large manufacturing plant build in Chicago.


312-***-**** Crystal Lake, IL

• Created and implemented a stage-gate process/roadmap for new product development cycle–still in use today, in partnership with R&D, contract manufacturing, packaging and chemical suppliers.

• Achieved reduction in Cost of Quality ($400K to $5K.

• Delivered $1M+ in cost savings and boosted company’s Adherence and Attainment rates to 99% by reducing the number of contracted manufacturers (30 to 3).

• Reduced Quality defects by 60% and saved $950K+ by use of LEAN Six Sigma-8D/ CAPA WILLIAM WRIGLEY JR. COMPANY September 2004 – March 2008 Public $5B+ chewing gum and confection manufacturer purchased by MARS, Inc. in 2008. Senior Specialist, Global Innovation Quality

Led Quality Management Systems across 19 global production facilities and successfully developed and launched company’s field-based “train-the-trainer” program for Global Factory Sensory Science and Consumer Testing (19 manufacturing sites, trained 45 panelists, & 67 new product developers). Led company-wide team-building committee to increase productivity and employee satisfaction. (Led cross-functional team to identify energy savings for pilot across 21 locations.) RQA, INC. July 2003 – September 2004

Global Quality Assurance & Risk Mitigation company that supports food, beverage, personal care & CPG industries. Lead Auditor / Project Manager for Quality Assurance Services

• Achieved Food Safe Lead auditor and managed 25+ field auditors for GMA (FPA) SAFE / Food Safe audits in support of domestic and international food, chemical, packaging and CPG manufacturer clients.

• Managed and cultivated winning client relationships with major accounts, e.g. ConAgra, Gerber, Kraft Foods & Sysco. PEPSICO September 1990 – June 2003

Fortune 500, $66B, CPG manufacturer that owns Pepsi, Quaker, Frito-Lay, Gatorade & more brands. Corporate Quality Supervisor

• Progressed from Lab Technician, Ingredient Coordinator, Operations /Quality Analyst Leader then promoted to Corporate Quality Supervisor over multi-sites and led operations / quality systems.

• Achieved Corporate Lead Auditor and lead teams to conduct company audits to ensure regulatory compliance.

(Responsible for FDA site visits, including successful remediation of findings & documentation)

• Developed and implemented cross-functional programs for LEAN Six Sigma, GMP, HACCP, Allergen Control, Sensory Compliance and Developed, Trained & Implemented QMS (SPC, Internal Audit /auditor Program, Risk Management Control Program, Sanitation)

o Delivered 25% decrease in Quality holds and 59% reduction in consumer complaints. Supervised Quality Management Systems across 14 facilities. Implemented color sorting, X-ray & Metal Detection Technology.


BACHELOR OF ARTS, General Studies – (MAGNA CUM LAUDE - 3.9) (Organization Studies, Psychology & Science), 2013 – Eastern Illinois University, Charleston, IL

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