*** ******* **** ****

Marstons Mills, MA *****

774-***-****

acxvmh@r.postjobfree.com

Lisa A. Miller

Experience

March 2015 – December 2016 Accudynamics, LLC Lakeville, MA

Quality Control Manager

Management Representative for ISO 9001:2008 registered company.

Responsible for all aspects of the Quality Management System including but not limited to Calibration, CAPAs, MRB, and Inspection.

Revitalized Internal Audit program.

Developed roaming inspections of the production floor; trended data to determine continuous improvement opportunities

Work with Purchasing Manager regarding supplier quality-related performance issues

Point person for customer audits, SCARS, and returns.

Developed electronic inspection records to eliminate waste, improve trending, and clarify requirements.

Manage team of five to ensure production and customer needs are met.

July 2014 – March 2015 Environmental Operating Solutions Bourne, MA

Customer Service Representative/Production Manager

Responsible for fulfilling customer needs from processing orders, communicating status and invoicing to ensure 100% customer satisfaction, with a focus on key accounts.

Provided support for Sales Team in order to establish and execute on customer expectations.

Assisted Logistics Manager with coordinating deliveries between contract manufacturers, third party carriers and customer sites.

Monitored inventory and ensured adequate inventory levels were maintained at all contract manufacturing sites.

Developed and implement company-wide Safety Program including writing procedures, providing training, and obtaining third-party certification.

Aug 2012 – Feb 2013 Onset Computer Corporation Bourne, MA

Sr. Operations Program Manager

Developed and maintained Operational metrics.

Implemented and led a 30-60-90 day forecast review process to support Lean initiatives.

Functioned as the major resource for the Operations Leadership team for monitoring, data extraction, analysis, set-up, trouble-shooting issues and resolving problems with the company ERP system.

Served as the Operations Team representative on new product development projects. Facilitated and coordinated interactions with members of Operations and Engineering to ensure new products were introduced on time and on cost-target.

Participated in a Kaizen event to streamline the manufacturing of one of the top three product families resulting in the development of a dedicated single-piece work cell.

Provided support to the Production and Manufacturing Engineering Managers in the selection of a SMT sub-contractor and other outsourced services in order to expand capacity and provide back-up as part of a Disaster Recovery Plan.

July 2009 – July 2012 Onset Computer Corporation Bourne, MA

Director of Operations

Responsible for developing and monitoring $2.8M budget.

Directed the Manufacturing, Purchasing, Quality, Manufacturing Engineering, Shipping and Receiving Departments. Implemented an Operations planning process that established concrete departmental and individual goals that aligned with Company goals; monitored progress.

Drove the establishment of a Material Review Board complete with a functioning corrective action system that lead to improvements with Suppliers and within the company.

Directed and supported LEAN programs such as 5S, one-piece flow work cells, standardized work stations and the development of formal preventative maintenance program.

Worked with the Senior Management team to develop and implement a gate-phased Product development process. Lead Operations Leadership Team in developing and defining the interdepartmental dependencies/tasks associated with the Operational phase activities and exit requirements. Co-developed phase exit readiness assessments and statement of supports.

Oversaw the successful transition of 30+ new products from Engineering to Operations. Assisted in the development of appropriate product pricing, cost, delivery schedules, and manufacturing methods.

Member of interdepartmental team tasked with implementing Company-wide ERP system with the focus on Operational modules. Developed and incorporated best practices into new/revised processes

Oct 2000 – July 2009 Onset Computer Corporation Bourne, MA

Director of Quality

Oversaw the Onset Quality Management program. Worked with various departments within the Company to establish and/or improve upon processes.

Managed Customer complaints and technical notifications. Provided field and product failure statistics to aid in investigation of product issues and provide product improvement opportunities.

Developed a customer satisfaction measurement system which consisted of quarterly and annual surveys; responsible for the deployment, analysis and presentation of results; provided recommendations based on customer feedback.

Facilitated and participated in a Continuous Improvement program that focused on establishing, supporting and monitoring manufacturing enhancements in equipment, processes and people. Program led to the investment of ~$1M in capital equipment improving manufacturing efficiency and quality

Developed Product of the Quarter initiative which focused on the top selling products; recommended and oversaw the implementation of process and design changes that improved cycle time and decreased failures.

Oversaw the Calibration, Change and Document Control systems. Had authority to approve or deny the release of new and existing products for sale.

Additional Responsibilities 2009

Production planning and scheduling.

Provided leadership to the manufacturing floor during extended absence of Production supervisor.

Facilitated a weekly product availability meeting which provided a vehicle for company-wide communication regarding new products, large potential orders, etc.

Lead a cross-departmental team tasked with the planning and logistics of transitioning products against a July 2009 deadline for new CE standards.

1995-2000 Associates of Cape Cod, Inc. Falmouth, MA

Quality Assurance Manager

Managed a team of ten; responsible for overseeing the Quality Control/Quality Assurance activities such as release testing, calibrations, validations, and incoming, in-process, and final inspection for all manufactured products. Reviewed batch records; had authority to approve/reject raw materials, in-process materials, and finished products.

Planned, reviewed, and monitored internal quality audits performed by an in-house audit team consisting of 4 members. Responsible for handling customer audits, performing vendor audits, and assisting in FDA audits.

Reviewed, monitored, and trended Non-Conformance Reports. Determined corrective and preventive measures when applicable.

ISO Management Representative; had the authority and responsibility for ensuring the requirements of ISO 9001:1994 were established, implemented and maintained. Chaired management review meetings held to assess and evaluate the company’s quality system.

Responsible for the coordination and control of the quality system documentation. Developed, wrote, revised, and approved standard operating procedures and quality systems procedures to meet current Good Manufacturing and ISO regulations.

Maintained employee in-house training program. Prepared and presented in-house training seminars on a variety of topics including GMP, ISO and new employee orientation training on quality awareness.

Education

Training

2002-2003 National Graduate School Falmouth, MA

M.S., Quality Systems Management

1983 - 1988 University of Northern Colorado Greeley, CO

B.A., Biology, minor Chemistry

Internal Auditor, Fundamentals of GD&T, Poke Yoke, Customer Satisfaction, Lean 101, GD&T, Transitioning to ISO 9001:2015

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