JOLENE M. JONES, MBA, CQA

****F FULLERTON COURT

MILFORD, DELWARE, UNITED STATES

302-***-****

acn6nw@r.postjobfree.com

PROFESSIONAL EXPERIENCE

DENTSPLY CAULK MILFORD, DELWARE

Quality Assurance/Regulatory Affairs Manager- Medical Device/Pharma May 2014 – January 2015

• Responsible for managing Quality Assurance and Regulatory Affairs for multiple facilities.

• Successful implementation of an electronic system, Pilgrim Smart Solve for use with Corrective

and Preventive Actions for multiple facilities.

• Excellent team leadership skills, mentoring, and people development skills using cross-functional

and Matrix training to maintain employee job satisfaction and organizational commitment for a team

of twelve employees.

• Strategic planning by assigning the appropriate resources and tools for the quality and regulatory

department.

• Obtained compliance to FDA 21 CFR 820, FDA 21 CFR 210, FDA 21 CFR 211, CFDA, JPAL,

Health Canada, ISO13485, Saudi Arabia regulations as a liaison for multiple facilities.

• Obtained compliance to FDA 21 CFR 820, FDA 21 CFR 210, FDA 21 CFR 211 including such

tasks as annual registration of medical devices, drugs and cosmetics, corrections and removals

(recalls) for the US FDA, China FDA, Health Canada, JPAL, EU and numerous other countries for

multiple facilities.

• Managed the supply chain by performing routine supplier audits and issuing SCAR's for multiple

facilities. Managed quality agreements with raw material suppliers, finished medical device

suppliers and intercompany suppliers.

• Excelled as the ISO13485 lead auditor for internal audits and the liaison for the facility during

external audits such as ISO13485 notified body audits/EN ISO13485 notified body audit and

Corporate Audits for multiple facilities.

• Improved all quality assurance functions throughout the facility including Internal Audits,

Document Control, CAPAs and Complaints to ensure compliance and increase efficiency for

multiple facilities.

BAXTER HEALTHCARE CORPORATION DAYTONA BEACH, FLORIDA

Quality Manager/QMR- Medical Device November 2009 – May 2014

• Successful implementation of multiple electronic systems. Implemented Trackwise 8 for use with

Corrective and Preventive Actions, Change Control Management for engineering changes, risk

management, ISO Train to track employee training, BPLM for document control and JDE, ERP

system for manufacturing.

• Excellent team leadership skills, coaching, and people development skills using cross-functional

and Matrix training to maintain employee job satisfaction and organizational commitment for a team

of ten quality engineers.

• Strategic planning by assigning the appropriate resources and tools for the quality department.

Compiled and implemented annual facility wide quality plan.

• Facilitated the integration of a highly complex global quality system while maintaining

continuous improvement strategies using DMAIC tools; Fish Bone Diagram, 5 Why Analysis and

Gap Analysis.

• Obtained compliance to FDA 21 CFR 820 regulation as an FDA liaison including such tasks as

annual registration of class II medical devices, class II lasers, medical device reporting, adverse event

reporting, corrections and removals (recalls).

• Exceed expectations upon delivering projects on time in highly regulated and time-sensitive

environments while maintaining a quality department budget of $4 M. Directed the multi-

department, facility wide management review process.

• Improved all quality assurance functions throughout the class II medical device facility including

MRB's, Complaints, Verification, Validation, FMEA, AQL Sampling for Incoming Inspection,

Document Control, Calibration, DHR, DMR, Labeling, Finished Device Acceptance, Device

Distribution, Pareto analysis and statistical analysis using Mini-Tab to ensure compliance and

increase efficiency.

• Managed the supply chain from initial supplier qualification, and by performing routine supplier

audits, issuing SCAR's, and monitoring supplier quality and delivery.

• Excelled as the ISO13485 lead auditor for internal audits and the liaison for the facility during

external audits such as FDA Routine Inspections and Corporate Audits.

IMPERIAL DESIGN, INC. (SAF-HOLLAND) GRAND RAPIDS/MUSKEGON, MICHIGAN

Quality Engineer- Automotive/Military May 2008 - March 2009

• Obtained ISO/TS16949 certification through the creation and implementation of a robust

ISO/TS16949 quality system standard for use in multiple lean manufacturing facilities that included

such tasks as process flows, controls plan, FMEAs, CAPAs (8D), Gage R&R's and process

capabilities.

• Drove continuous improvement through gap analysis, pareto analysis and the training of the

quality assurance team on sustaining quality management system compliance.

• Excelled as the ISO/TS16949 lead auditor for internal, external, product and process audits.

ENGINE POWER COMPONENTS GRAND HAVEN, MICHIGAN

Quality Engineer January 2007 - November 2007

• Sustained quality system compliance to ISO/TS16949 standard for use in a lean manufacturing

facility by performing PPAPs, APQP, MRB's, CAPA (8D), document control, complaints, statistical

analysis, FMEA, process flows, control plans, AQL inspection, quality alerts and all personnel

training compliant.

• Maintained the quality system using continuous improvement strategies using DMAIC tools; Fish

Bone Diagram, 5 Why Analysis, Poke Yoke, Gap Analysis, 5S, SPC, Gage R&R and Capability

Studies.

• Excelled as the ISO/TS16949 lead auditor for internal audits, supervised inspectors and auditors

while performing as the facilities' liaison during external audits.

METOKOTE CORPORATION GRAND RAPIDS/LAPEER, MICHIGAN

Quality Manager/Deputy Plant Manager/QMR- Automotive May 2003 - January 2007

• Facilitated quality system integration from ISO9001 to ISO/TS16949 certification for use in

multiple lean manufacturing facilities that included such tasks as process flows, controls plan,

FMEAs and CAPAs as well as assisting four other facilities in the same process.

• Reduced internal PPM's 50% and external PPM's 85% by creating visual inspection standards for

employees.

• Successful implementation of SQC Pack software for SPC and statistical analysis and Gage R&R.

• Excellent team leadership skills, coaching, and people development skills using cross-functional

and Matrix training to maintain employee job satisfaction and organizational commitment while

assuming the roles of QMR, HR Representative and Deputy Plant Manager.

• Strategic planning by assigning the appropriate resources and tools for the quality department.

Compiled and implemented annual facility wide quality plan.

• Directed the multi-department, facility wide management review process.

• Exceed expectations upon delivering projects on time in highly regulated and time-sensitive

environments while maintaining a quality department budget of $2 M.

• Sustained quality system compliance to ISO/TS16949 standard for use in a lean manufacturing

facility by performing PPAPs, APQP, MRB's, CAPA (8D), document control, complaints, statistical

analysis, FMEA, process flows, control plans, AQL inspection, quality alerts and all personnel

training compliant.

• Excelled as the ISO/TS16949 lead auditor for internal audits for multiple facilities, product and

process audits while performing as the facilities' liaison during external audits (customer, registrar

audits and ISO14001 Environmental audits).

• Managed the supply chain from initial supplier qualification, and by performing routine supplier

audits, issuing SCAR's, and monitoring supplier quality and delivery.

• Maintained the quality system using continuous improvement strategies using DMAIC tools; Fish

Bone Diagram, 5 Why Analysis, Poke Yoke, Gap Analysis, 5S, SPC, Gage R&R and Capability

Studies.

FEDERAL MOGUL ASSEMBLED CAMSHAFTS, INC. GRAND HAVEN, MICHIGAN

Document and Data Control Coordinator- Automotive February 1999 - February 2002

• Obtained ISO9001 certification through the creation and implementation of a robust ISO9001

quality system standard for use in a lean manufacturing facility that included such tasks as document

control, process flows, controls plan, FMEAs, Process Flows, Control Plans, CAPAs (8D).

• Excelled as the ISO lead auditor for internal, product and process audits while performing as the

facilities' liaison during external audits

MERIDIAN, INC. SPRING LAKE, MICHIGAN

Assembler- Office Furniture September1993 – August 1998

• Team Lead commissioned with the tasks of training all new personnel as well as maintaining all

aspects of the work cell line.

EDUCATION

BAKER COLLEGE CENTER FOR GRADUATE STUDIES FLINT, MICHIGAN

MBA, Dec 2012

• MBA with a focus in Leadership Studies

BAKER COLLEGE FLINT, MICHIGAN

BA, Sep 2010

• BA with a minor in Marketing

CERTIFICATIONS

• ASQ RABSQA Certified Lead Auditor (ISO9001, ISO13485), AQS, April 2012

• Certified Internal Auditor (ISO9001, ISO/TS16949), Excel Partnerships, April 2005

• Certified HR Specialist, Michigan State University, June 2006

Contact this candidate