Quality Assurance Complaint Handling Supervisor

REBECCA M. GONZALEZ

**** *********** • San Antonio, TX 78261 • 210-***-**** • ******************@*****.***

OBJECTIVE Seeking a position where my analytical, management, and team leadership talents will be of value with

an organization offering new career challenges

SUMMARY • Offering a Bachelor of Business Administration with a concentration in International Business,

with an extensive quality control and regulatory compliance record supporting both domestic and

international operations. Exemplary experience on behalf of FDA, MHRA, Health Canada, and ISO

related requirements.

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• Senior auditing management talents. Prepare company for multiple internal, FDA and ISO audits.

Key contributor to standardization of processes/procedures requiring continuous development of

internal/external policies and documentation to ensure effective compliance results.

• Cross functional Team Leader and Life-Cycle Project/Change Manager. Accountable for

program/project scope, risk assessment, functional/technical specifications, supervising and training 30-

member teams, and cross-functional communications to achieve regulatory/quality goals.

• Evolve new products from raw materials to post market status, integrating tracking, trending, and

quality metrics. Analyze overall product impact and team lead resolution of product shortcomings.

• Manage and establish effective communications platforms between international and domestic

partners to facilitate company transitions throughout corporate acquisition and merger processes.

Kinetic Concepts, Inc. USA & ArjoHuntleigh, Inc, Sweden. 11/02 to 06/14

EXPERIENCE Quality Assurance Complaint Handling Supervisor, San Antonio, Texas

06/09 to 06/14 • Primary company representative providing quality oversight with regulatory bodies such as FDA, ISO,

MHRA, and Health Canada, integrating cGMP and QSR criteria.

• Examined issues through root cause analysis throughout initial complaint to case closure. Created and

forwarded complaint data queries to multiple units i.e. Engineering R&D, Post Market Surveillance,

CAPA Analysis, Risk Management, Supplier Quality Audits, and Management Review units.

• Designed and implemented numerous system enhancements to stream line the complaint handling

process. Developed Standard Operation Procedures and QP documentation, as well as complaint

closure templates using product and allegation codes to enhance accuracy of the auditing process.

• Served as a cross functional collaborator with multiple departments i.e. call center, customer technical

support, field service, engineering, and manufacturing groups to amass compliance data.

• Conducted ongoing product device evaluations and review. Facilitated and investigated reportable

events involving interviews with legal, medical, and engineering teams.

• Provided significant involvement in both internal and external audits throughout tenure. Conducted

personnel training within all appropriate departments.

• During major company acquisition, coordinated with both companies to align and provide synergy

regarding medical device interpretations, focus, and regulations. Integrated a sales perspective for

European customers and rental perspective for USA customers.

• Upon hire, completed backlog project of potentially reportable event complaints to on-time processing.

Personally closed over 3,000 potentially reportable complaints while adjusting to a conversion from the

Legacy system to new database and software.

• Directed ongoing lengthy complaint investigation processes integrating medical/nursing reporting, field

service pre/post equipment events, engineering and quality input. Added variables such as volume of

complaints for both new and established product lines to identify acceptable thresholds and push for

further corrective or preventative actions.

• Established and managed a communication platform pertinent to 19 different departments considered

critical to domestic and international operations.

• As a team leader, conducted the majority of interviews, training, and work assignments for a 30-

member temporary team, as well as a small permanent staff. Authored a training manual for

temporaries to expedite training for the transitional group.

• Delivered briefings and met regularly with executive team leaders including Vice Presidents and Senior

Directors to discuss and resolve comprehensive operational issues affecting sales, recalls etc.

01/08 to 06/09 • Promoted from a Quality Assurance Complaint Handling Analyst, for performance excellence.

11/02 to 12/07 Assembly Supervisor, San Antonio, Texas

• Team led a 30 member team in all aspects of daily production. Managed qualitative and semiannual

performance reviews including personnel counseling to ensure top employee production levels.

• Managed production phases from receipt of raw materials throughout assembly, packaging, and

shipping.

• Conducted continuous training regarding SOP’s, quality, safety, ISO 9000, and FDA requirements.

• Managed inventory control, in addition to budgets and production performance levels to maintain cost

efficiency. Completed timely GAAP analysis of work order labor and material variances.

• Effectively coordinated with multiple departments regarding the implementation of new products into

the production line. Collaborated with engineering, procurement, quality assurance, and research and

development to ensure on-time launch launches in accordance with product development procedures.

• Implemented ongoing engineering changes and deviations as required, and conducted root cause

analysis regarding materials, quality, and assembly processes.

• Co-authored work instructions, testing procedures, and appropriate documentation for production.

• Successfully completed training and implemented Lean Manufacturing concepts which included Just In

Time Delivery and One Piece Flow Manufacturing.

• Promoted to Quality Assurance, for excellence in job performance. Continually produced quality

operations on behalf of high dollar product lines.

07/00 to 11/02 Special Markets/HVAC Sales Coordinator, Friedrich Air Conditioning Co., San Antonio, Texas

• Directed all customer orders for a special mobile home product line. Tracked and reported

production and shipping statuses on an ongoing basis.

• Collaborated with purchasing to ensure accurate inventory and supply levels met customer demands.

Cross-trained in approximately 10 different departments i.e. credit, logistics, production etc.

• Administrative actions included automated preparation of production orders, new models, current labor

tickets, scrap items, and data entry auditing to support production control.

• Authored and updated production packets for all factory supervisors and managers on a daily basis.

• Primary representative tasked with diplomatically resolving internal/external customer complaints and

production issues. Maintained top customer satisfaction and relationship building throughout tenure.

• Supported premier client satisfaction by conducting premise visits to client facilities and obtaining

updated feedback regarding client requirements. Applied information to improve company processes.

Prior to 2000 Department Manager, Miller Curtain Company, San Antonio, Texas

• Directed supervisor/associate training, and production logistics on behalf of production packaging

product for local and national clients. Utilized forecasting and cross-functional communications to

quickly identify problems, diagnose root causes, and implement corrective actions.

EDUCATION Bachelor of Business Administration with a concentration in International Business, University of

Texas at San Antonio, 12/97

PROFESSIONAL DEVELOPMENT

• Trainings - The FDA Inspection Process: From SOP to 483, Identification of Countries

Deviations/Difficulties from MEDDEV, Key Factors to Write and Effective Standard Operating

Procedure (SOP) and Working Instructions (WI), Medical Device Complaints: Strategies for Managing

Your Biggest Compliance Challenge, Understanding Complaints (21 CFR – 820), FDA's New

Enforcement of 21 CFR Part 11, Understanding Differences in EU and US Medical Device Regulations,

Understanding Differences in US and EU Medical Device Adverse Event Reporting, Compliant Device

Design – ISO 14971 • Additional upon request

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