Director of Quality

Kimberly Keown

Powell, Ohio *****

Director, Manager of Quality

Accomplished business leader with over 19 years of hands on experience and proven ability to successfully devise and direct quality solutions. Highly successful in identifying opportunities for improvement while also reducing cost and waste, and streamlining processes.

Areas of Expertise

● Quality Management ● Operations Management ● Process Mapping/Design ● Regulatory Compliance

● ISO Compliance/Auditing ● Six Sigma / Lean ● Team Development and Leadership

● Operational/Business Analyst ● Cost/Waste Reduction ● Document/Change Management

● Process/Continuous Improvement ● Vendor/Supplier qualifications and relations ● Project Management

● Root Cause Analysis ● SPC/Metrics/Scorecard/KPIs ● Planning & Budgeting ● New Business Integration

● Accreditation (URAC, ACHC, JCAHO )

Technical Skills / Knowledge

• 19 years experience within Manufacturing, Supply Chain, Logistics, Assembly and Pick Pack

environment

• 10 years experience within QC/QA related processes

• Advanced user of all Microsoft apps, including: Access, Excel, Word, Microsoft Project,

SharePoint, Publisher, PowerPoint, Visio

• Pharmaceutical Distribution/ Dispensing

• Expert at Process Mapping and Visio

• Data Collection/SPC Analysis (Performance Metrics, Business Analysis, Key Performance Indicators)

• Process Improvement

• Compliance (HIPAA/PHI, Medicare, Regulatory)

• Experience using Business Objects, SAP, APS, Agile, BaaN

• Lean Manufacturing / TQM ● Safety, EHS, 5D ● Kaizen/Kanban

• DMAIC , CAPA, COPQ, 8D ● Six Sigma / ISO ● ERP/MRP Systems

Executive Skills

• Demonstrated ability to lead and empower others

• Ability to organize, manage and motivate cross-matrixed teams to meet agreed upon business

objectives

• Proven ability to drive strategies enhancing both customer satisfaction and exceeding company goals

• Excellent record of advanced root cause analysis and implementing corrective/preventative quality

solutions

• Strong business acumen

• Extensive experience in interpreting standards/contracts requirements and applying improvements

and/or upgrades to meet these standards.

• Broad knowledge of proper business analysis and performance metrics to identify improvement needs.

• Effective interpersonal skills (e.g. partnering, conflict management, mentoring) with strong

verbal and written communication skills

• Hands-on technical knowledge of all manufacturing, supply chain and logistics operations

• Experience translating customer requirements into formal agreements and plans to culminate in

customer acceptance of results, while meeting business and contractual objectives

• Vast experience developing projects from conceptual phases through project close-out including

scope development, change management, cost estimation, system design, risk assessment, equipment

selection, procurement, installation and resource allotment.

Professional Experience

Director of Quality and Compliance – BioScrip Pharmacy Services, Inc. May 2010 – Present

• Developed and implemented a Quality Management System for multi-site organization

• Created all processes and policies required for URAC accreditation and regulatory requirements

• Achieved URAC accreditation for multiple sites

• Developed and implemented Internal Auditing Team

• Programmed and Implemented QC database for all error collection and reporting

• Established CAPA program that has reduced cost (YTD) of errors and waste by 56%.

• Designed and programmed application for customer service issue tracking

• Created Quality Score Card metrics

• Established departmental Key Performance Indicators

• Implemented multi-site quality training program

Project Manager – Cardinal Health (Adecco Contract) June 2009 - May 2010

• Developed detailed Project Plans for Private Label Launch/Resource activities

• Created, Designed, Implemented and maintained SharePoint Team Site for Project collaboration,

template repository, Project documentation reference and collection, and Supplier Contracts.

• Created database for Supplier Contracts w/ reporting mechanism.

• Conducted cross-matrixed sessions to created detailed process steps and capture departmental

requirements.

• Tracked Project deliverables and forecasted impact to schedule

Quality Manager – Zomax formerly Metatec, Dublin, OH Dec 2006 - Mar 2009

• Directed and completed all activities required to achieve ISO 9000 certification/compliance

• Prepared and executed the site Quality Manual, Quality Plan and Quality Objectives

• Developed Internal Auditors training material

• Responsible for creating and/or approving all site procedures, work instructions (SOP’s) and

corrective actions

• Established and reported all departmental KPI’s

• Reduced scrap and waste by $190,000 (COPQ) over a two year period by implementing process

improvements to reduce re-manufacturing and re-processing costs

• Captured, classified and reported all internal/external non-conformances by trend, root cause and

gap analysis using SPC techniques and metrology to identify preventative and corrective actions

needed

• Decreased errors of all managed areas by 98%

• Championed cross-functional process improvement teams and effective corrective actions to reduce

Non Conformances by 97%

• Performed all diagnostic testing on returned media/product

• Reviewed contractual and technical documents to determine and implement strategic planning for

quality control

• Responded to quality concerns/questions of RFQ’s and SOW’s

• Determined metrics, collected data and devised reporting mechanism for Scorecard distribution to

executive management

• Maintained and created database tracking for all quality reporting (Non-Conformances, Vendor

Performance Tracking, CAPA)

• Developed ASQ level inspections and processes for inbound inspections

• Responsible for hiring, training and directing staff as well as site wide quality process training

• Resolved conflicts within project and/or process improvement teams

Audio Engineer – Cinram formerly WEA/WAMO Manufacturing, Olyphant, PA May 2001 - Sept 2006

• Performed all Audio encoding, QC Analysis, digital editing/correction, sound to picture

corrections, format and time code conversions for major DVD releases. (Warner Bros, New Line,

Lions Gate, HBO, Universal, Sundance Channel)

• Performed DVD-Audio and DVD-Video authoring and title QC analysis

• Developed studio design, wiring scheme and equipment location/integration to optimize work flow

and efficiencies

• Created and implemented departmental ISO procedures and detailed training manual

• Researched and developed new service offerings for DVD-ROM and DVD-Video and presented client

demonstrations

• Served as technical contact for internal and external customer issues

• Maintained, calibrated and repaired all studio equipment

• Maintained database of all projects processed and delivered profit analysis reports

• Responsible for troubleshooting and process analysis to determine root cause of title malfunction

or playability issues

Technical Manager - Metatec International – Dublin, OH (now Zomax) April 1992 - May 2001

Audio Technician 1992-1993

Supervisor Audio Premastering 1993-1995

Manager Premastering Services 1995-2001

• Performed beta testing for software vendors

• Responsible for budget planning and adherence

• Established pricing for all services offered

• Trained, hired and supervised all associates

• Managed all processes and developed detailed ISO procedures, training materials and technical

standards

• Researched and implemented new service offerings

• Served as ISO lead auditor

• Maintained and calibrated all equipment/software/hardware

• Responsible for the purchase and installation of all equipment

• Established and maintained vendor and customer relationships

• Prepared and presented quality information, problem resolution and service updates to Executive

team

• Maintained a less than .01% non-conformance record within all managed departments

• Participated in pre-sales/marketing processes to understand customers’ expectations and implement

processes to meet these requirements

Professional Growth

• Kaizen, Kanban & Lean Manufacturing Principles/Tools : Definity Partners, Columbus, OH

• ISO 9000 Quality Systems Internal Auditor Development Course: Scranton,PA / Columbus,OH

• Sonic Solutions/DAW/DVD Training Course: Novato, CA

• Dale Carnegie Leadership Training: Metatec, Dublin, OH

• DVD Authoring Course: UCLA, CA

• NAB (National Association of Broadcasters) seminars and exhibitions: LasVegas, NV

• AES (Audio Engineering Society) seminars and exhibitions

• Production Assistant for Grammy Winning Album: Earl Wild, classical pianist

Education

Bachelor of Science Degree: Ball State University, Muncie, IN

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