Sample Resume  - "Combination":

Wendy Soronovich
9935 W. 31^st StreetMy City, CA 9200
Cell: (619) 333-2222
Wsoro123@hotmail.com

OBJECTIVE: Corporate Internal Auditor, Supplier Auditor, or Quality System Trainer.

KEYWORDS: Quality System, QA, QS, Audit, Good Manufacturing Practices (cGMP), International Standards (ISO), Corrective and Preventive Action Programs (CAPA), training, QSR, Medical Device, calibration, 510K, TQM, PMA, FDA.

Corporate Auditing:

ISO and GMP/Quality System Regulations. This entailed both internal and supplier audits.

Management, Quality Control Department:

Managed a project team that prepared documentation for litigation. This entailed controlling the logistics of depositions and exhibits for legal counsel.

Responsible for Receiving Inspection, Manufacturing Final Inspection, Packaging Inspection, Product Release, Device History Records, and the Calibration function. Set up and maintained the department budget. Member of the Change Review Board, and the Material Review Board.

Regulatory Affairs / Quality Assurance:

Primary representative for all regulatory agencies regarding postmarket surveillance, Medical Device Reporting, Vigilance Reporting, and product recalls.

Developed work instructions and Standard Operating Procedures for product recalls, customer complaints, Medical Device/Vigilance reporting (GMP/QSR and ISO), in-coming and in-process inspection, product release, calibration system, CAPA system, and maintaining Device History Records, Training Programs.

Prepared Medical Device Reports to the Food and Drug Administration, and Vigilance reporting to the International Competent Authorities.

Training/Presentations:

Trained domestic and international personnel on regulatory compliance in accordance to the Quality System Requirements, Medical Device Reporting, Medical Device Directives, CE Marking, and ISO Vigilance Reporting. Conducted the annual training on the ISO (9001/13485/EN46001) Requirements and Quality System Regulations. Conducted annual reviews on Safe Lifting, and Electrostatic Discharge (ESD).

EXPERIENCE:

2003 – PRESENT Company A San Diego, CA
Principal Quality Assurance Specialist

2000 - 2003 Company B San Diego, CA
Sr. Quality Assurance Specialist

1995 - 2000 Company C San Diego, CA
Quality Control Department
Principal Regulatory Affairs Specialist

1990 - 1995 Company D San Diego, CA
Quality Affairs Department
Regulatory Affairs Specialist

1982 - 1990 Company E Pittsburgh, PA
Quality Assurance Specialist

EDUCATION:

1994 California State College of Pennsylvania , Elementary Education, BS

PROFESSIONAL SOCIETIES:

American Society of Quality - Certified Quality Auditor (CQA)
Regulatory Affairs Professionals Society - attended the class for RAC certification..
San Diego Regulatory Affairs Network - Board member.