Quality Control Assurance

Paula Heiss

** ****** ****** ********, ***** Island 02910

(401) 580-

**** / *************@***.***

SUMMARY OF QUALIFICATIONS

Experienced in Quality Supervision and Engineering. Effectively achieved

timely resolution of quality related issues through building successful

and cohesive solution teams. Well organized, detail-oriented, proficient in

communicating with others at all levels. Willing to go "above and beyond"

to meet objectives and goals, and hold self accountable;

decisive...dedicated...conscientious.

PROFESSIONAL EXPERIENCE

SEALED AIR CORPORATION, Cranston, Rhode Island

2010-2013

Custom Thermoforming: Packaging and Containers 13485 & 9001 ISO Certified

QUALITY / PROCESS ENGINEER

Primary responsibility was to assure that the customer's specifications met

the item produced through technical interface between Engineering and

Manufacturing. Specific responsibilities included coordinating

investigations and containment activities for corrective actions. Led cross-

functional teams in solving quality related production problems.

Interpreted inspection requirements for manufacturing personnel. Developed

inspection methods for use by inspectors during production. Executed Design

of Experiments (DOE) for sealing machines and sealing operations as

requested by customers. Analyzed various specifications and prints to

identify existing and potential quality problems in support of robust

product designs. Possessed intimate knowledge of First Article and

Validation processes through product launch. Conducted internal/external

audits. Responsible for customer and supplier corrective actions. Familiar

with QA Macros software.

Accomplishments:

. Successfully validated 3 newly constructed clean rooms and 1

gowning room.

. Achieved significant reduction(>95%)of packaging & shipping errors.

. Created & implemented Current Good Manufacturing Practices (cGMP)

Audit Program for Class 8 clean rooms. Maintained optimal

environmental conditions via monthly particulate monitoring of

clean rooms.

. Managed Internal Audit Program in support of ISO readiness.

CONTECH MEDICAL, Providence, Rhode Island

2009-2010

Medical Device: Dispenser Tubing and Dental Components 13485 & 9001 ISO

Certified

QUALITY ANALYST/CORRECTIVE AND PREVENTIVE ACTION(CAPA)ADMINISTRATOR

Administered, reviewed, and closed CAPAs, initiated and reviewed document

(SOP&WI) changes, evaluated vendor profile surveys and maintained database,

completed customer surveys and maintained database, assessed internal and

external audit results and suggested methods of improvement, managed

Inspector Quality Training Program, communicated with vendors and customers

as necessary in reference to quality issues. Conducted DOEs to achieve

desired prototypes for Sales Department.

Accomplishments:

. Created and implemented Inspector Quality Training Program.

INNOVATIVE SPINAL TECHNOLOGIES (IST), Mansfield, Massachusetts

2006-2008

Medical Device: Spinal and Cervical Implants and Instruments 13485 ISO

Certified

QUALITY SPECIALIST

Senior Quality Control Specialist in charge of the Quality Control Lab.

Scheduled and executed raw materials testing and research & development

(R&D) testing, trained new technicians (internal/external) at manufacturing

facilities, audited Device Master Records (DMR) and Device History Records

(DHR), provided R&D support detailing specific types of testing such as

ASTM, conducted documentation review, reported monthly metrics for Quality

Control Department, managed calibration database for all quality control

inspection instruments, maintained Food and Drug Administration (FDA)

supplier compliance database, and assisted with corrective and preventive

action (CAPA) evaluations.

Paula Heiss Page

2

Accomplishments:

. Developed and maintained excellent rapport with colleagues including

R&D, Manufacturing, Operations, Quality Assurance, as well as

suppliers and customers.

. Organized Quality Control Lab; trained internal/external technicians.

. Member of the internal/external Auditing Team.

NEW ENGLAND METAL FORM, Plainville, Massachusetts 2002-2006

Metal and Plastic Fabricators of Components and Finished Goods for various

industries, including Medical Device Industry 9001 ISO Certified

QUALITY ASSURANCE/CONTROL SUPERVISOR

Supervised inspectors, trained and supervised machine operators in

inspection techniques. Ensured proper quality inspection techniques were

utilized via training in use of various forms of measuring equipment and

statistical process control (SPC). Assisted with inspection of raw

material, work in process (WIP), and finished goods using micrometers,

calipers, indicators and CMM. Liaised between company owners, engineers,

customers and suppliers. Generated nonconforming material reports,

corrective action reports, and monthly scrap reports.

Accomplishments:

. Demonstrated ability to make the right decisions in a timely fashion

and hold self accountable.

. Created and implemented Measurement Training Program.

EDUCATION

RHODE ISLAND COLLEGE, Providence, Rhode Island

INDUSTRIAL TECHNOLOGY PROGRAM(93 credits)

Concentration: MANUFACTURING PLANNING & CONTROL

BECKER COLLEGE, Leicester, Massachusetts

ASSOCIATE OF SCIENCE/ANIMAL HEALTH TECHNICIAN(60 credits)

CERTIFICATIONS

ASQ

Certified Quality Technician

ASQ Certified Quality Auditor

ADDITIONAL TRAINING

OSHA Blood Borne Pathogen & Universal Precautions; Geometric Dimensioning &

Tolerancing; Standard Operating Procedures (Corrective & Preventive Action,

Deviations, Nonconforming Material Review, Inspection, Calibration, Control

of Documents, Control of Labels). Spine Training; Kit Processing Radiation

Protection; How to Handle an FDA Inspection; Quality System Regulation;

ISO 13485; Quality Policies; Complaint Handling.

Professional membership information available upon request.

Contact this candidate