Management Quality

Daniel Spears ****

Longshore Dr.

408-***-**** (home) San

Jose, CA 95128

408-***-**** (cell)

**********@*****.***

SUMMARY OF QUALIFICATIONS

** ***** ** ********** **** in-depth knowledge of quality (QMS) and

documentation systems. Have thorough knowledge of FDA, GMP, ISO 9001/13485

requirements, with excellent project management skills to manage and lead

the organization through the ISO certification process. Excellent computer

skills, thorough knowledge of bill of material structure and change order

process. Strong leadership and excellent communication skills, team player

with attention to detail and capable of multi-tasking in a fast paced

environment.

PROFESSIONAL

Caliper Life Sciences, a Perkin Elmer Company

Quality Assurance Supervisor 10/2012

- Present

. Implemented and maintained Quality Management Systems in compliance

with FDB regulations, and International standards (ISO9001/ISO13485)

for Microfluidics chip and reagent manufacturing.

. Managed the successful implementation of ISO13485 certification for

the site. Supervised and coordinated the activities of a Project

Manager for upgrading QMS system to ISO13485. Created and implemented

new procedures Risk Assessment, Process Validation, and Customer

Complaint Handling.

. Manage validation activities, and maintain all validation files and

reports.

. Manage (pFMEA) Risk Assessment activities in accordance with ISO14971.

Maintain all Risk Management files and reports.

. CAPA Coordinator. Create CAPA's related to NCR's, audit findings, and

customer complaints. Track, and create reports to present to Quality

Management Team for effectiveness review and closure.

. Internal ISO9001/ISO13485 auditor. Manage all internal audit schedules

and reports.

. Co Quality Management Representative for external audits.

. Member of the site Quality Management Team. Chair meetings; create

presentation reports for ECO, CAPA, and Calibration tracking.

. Coordinate our QMS system to be in sync with our corporate office in

Hopkinton, and product design site in Alameda.

. Received Perkin Elmer "Hero Award" for "Contributions made towards the

goals, values, and business objectives for Life Sciences & Technology"

related to the successful ISO13485 site certification.

. Continued to do all job functions from previous Document System

Analyst title (see below)

Caliper Life Sciences

Document System Analyst 06/2008

- 10/2012

. Worked in the Document Control department for an ISO 9001/ISO13485

medical device facility manufacturing microfluidics chips and reagents

employing just under 50 employees.

. Responsible for implementing and managing the change control system

using Agile and Oracle Item Master systems.

. Coordinate the modification & release of, new products, procedures,

drawings, bill of materials, labeling and training records via Agile.

. Interface with R&D, Manufacturing, and other Document Control

personnel at multiple sites.

. Agile Site Administrator. Responsible for training, maintenance, and

all information contained within Agile.

. Calibration Coordinator. Track, schedule, and file calibration

certificates for all production tools and equipment.

. Manage the filing and storage of all quality records, and DHR

documents. (onsite and offsite)

. Successfully added all customer product user/quick guides, and MSDS's

to the company internet website. Created process and procedures to

control the addition and updates to the documents on the website.

. Successfully transitioned the facility from a total paper system

processing NCR's, and CAPA's to an electronic system via Agile

database.

Beckman Coulter, Inc.

Project Administrator 04/2001

- 06/2008

. Worked in the Document Control department for an ISO 9002:1194 medical

device mfg facility employing approximately 230 employees.

. Responsible for implementing and managing the change control system

through Oracle Item Master systems.

. Coordinate the modification & release of procedures, drawings, bill of

materials, labeling and other controlled documentation. Maintain

electronic documentation (work instructions, procedures, and

engineering drawings) via Documentum Enterprise Document Management

System (EDMS), interface with R&D, Manufacturing, and other Document

Control personnel at multiple sites (including international sites).

. Successfully transitioned the facility from a total paper system

containing all employees training records, Engineering drawings, and

Procedures to an electronic system via EDMS database.

. Transitioned the site from a total paper system processing engineering

change orders to an electronic system via Lotus Notes database.

. Trained employees on how to use, Oracle, and Lotus Notes systems.

. EDMS Site Administrator. Added new users, setup and maintained access

control lists (ACL's), and conducted training classes for employees.

. Internal ISO9001 Auditor.

Beckman Coulter, Inc.

Engineering Product Planner 03/2000 - 4/2001

. Participate on Project development teams and work with the engineers

and design drafters to identify priority items, implement work

schedules, and expedite the setup of bill of materials to meet product

release schedules and goals.

. Support Product Development and Manufacturing by setting up and

maintaining all new and current product part numbers, bill of

materials, and revision controls in our AMAPS system. Lead the

Engineering change order process, chair meetings and coordinate the

drawing and system implementation. Maintain and control all

Engineering product drawings and procedures.

Beckman Coulter Inc.

Engineering Document Coordinator 05/1994

- 03/2000

. Lead the Engineering change order process, chair meetings and

coordinate the drawing and system implementation. Maintain and control

all Engineering product drawings and procedures. Support Product

Development and Manufacturing by setting up and maintaining all new

and current product part numbers, bill of materials, and revision

controls in our AMAPS system.

. Worked on team to gain ISO certification for our site.

. Maintained all Quality procedures per ISO9001 requirements.

EDUCATION

Training Courses:

Quality Systems - QMS, GMP, FDA Regulations, CPI (Continuous Process

Improvement Principles and Practices), TQC (Total Quality Control),

ISO9001/ISO13485 regulatory requirements, ISO13485 Internal Auditor

Training (P-E Handley-Walker, Inc.), Global CAPA Concepts, and CAPA ARP

Action Responsible Person

Documentation Systems - Agile System & Administration, Oracle Item

Master/BOM/iProcurement, Documentum (EDMS) System & Administration, Good

Documentation Practice Guidelines, Smart Team (file management)

Management Training - Global Management Development Curriculum (GMDC),

Leadership: The Critical Difference (San Diego State Univ. Seminar),

Excellence in Leadership II, Team Building Rules and Responsibilities,

Project Management Tools and Techniques

Computer Training - MS Windows, MS Office - Word, Excel, Access,

PowerPoint, Visio, Adobe Acrobat Professional, SharePoint, Lotus Notes Mail

and database training

Manufacturing Concepts - Lean manufacturing, Value Stream Mapping Workshop,

RoHS compliance, APICS Inventory Management (Santa Clara Valley Chapter)

Foothill College Working on AS Degree (Major, Data Communications &

Net Management)

Los Altos, CA Current GPA: 3.727

Technical Classes

Business Writing

Management and Supervision

Certification Classes

Microsoft Certified Software Engineer (MCSE)

Windows

Windows Server

Windows Active Directory

Windows Network Infrastructure

Designing Windows Active Directory

Designing Windows Network Infrastructure

Designing Windows Network Security

Upgrading and Repairing PC's

References available upon request

Contact this candidate