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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000

 

xxx-xxx-xxxx (H xxx-xxx-xxxx  (M)

Abc@xyz.com

 

Senior Operations / Technical Manager

Results-focused Quality Assurance/Regulatory Affairs Specialist eager to contribute expertise in medical device/equipment manufacturing industry toward supporting a progressive company in maximizing product integrity and standards compliance.

 

Qualifications Profile

 

Ø  Strong technical background with the ability to work independently on multiple research projects with specialized knowledge of state and federal regulations, budgetary control and analysis, adherence to ISO, GMP, and CE standards, as well as management and leadership of Q/C teams.    

Ø  Strategically plan, develop and administer Quality Assurance Programs to maximize use of resources, contain costs and boost profits. 

Ø  Multiple years of experience as an Quality Assurance Manager in the manufacturing and medical device sectors.

Ø  Excel in defining and implementing policies, procedures and operational systems that boost productivity, efficiency and quality of operations.

Ø  Competent leader and mentor who is able to create a team environment, including building collaborative relationships, training peers to perform at maximum efficiency, and the capacity to form cross-functional coalitions in order to ensure knowledge is shared across departmental lines.

Ø  Consistently focus on ensuring development of efficiency best-practices. 

Ø  Proven ability to adapt strong safety and technical skills to diverse organization needs.

Ø  Technology savvy and proficient in multiple software applications and hardware systems.

 

 

Key Achievements    

 

Ø  Reduced scrap 18.5% by developing improved process controls

Ø  Lowered vendor reject rate from 1.1% to .3% by reviewing their entire process to assure they meet our purchasing standards

Ø  Increased component receipts from 1.6 to 3.5 million parts while maintaining Inspection headcount, by requiring specific process controls at the suppliers

Ø  Reduced critical product label rejections from 49.7% to 5.1%

 

 

Professional Career Track

 

  Director of QA/RA, Precision Technology Inc.                                                                      0000 xxxxxx xxxx , xxxx , xxxxx 00000:2003 registration.  Additional functions include;

  Executing internal audit protocols designed to uncovered numerous non-conformities and lead corrective actions process in restructuring all operating methodologies;

  Interfacing with client base to ensure confidence by building customer focused Quality System;

  Directing ISO/GMP training, pFMEA, Document Control and Material Review Board;

  Act as Management Representative to oversee all CAPA and vigilance activities.

 

 

Associate Director of QA/QC, Siemens/DPC Cirrus                                                                1997-2007

 

  Primary responsibilities included oversight and management of 14 personnel staff involving Recall, Medical Device Reporting and required follow-ups with the FDA as well as communication with European affiliates to assure adherence to GMP, ISO and CE standards.  Specific functions included;

  Maintained workflow through Receiving, In-Process and Final Inspection test points;

  Performed internal, supplier and affiliate audits and reviewed and approved corrective actions;

  Chaired Material Review Board and authorized design, document and process changes;

  Created and monitored departmental budgets, coordinated UL, ISO, FDA and customer audits and administered training of GMP, ISO.

  Acted as member of Risk Management team and monitored quality indicators both internally and externally;

  Led and directed Continuous Improvement Team and managed vendor program, including annual forum for zero-defect, cost of rejection trending, process controls and historical performance data.

 

Quality Supervisor, Howmedica/Pfizer                                                                                      1990-1997

 

  Primary responsibilities included management and oversight of staff of 60 union employees.  Specific functions included;

  Designed and executed development of 2nd shift Quality and Packaging functions to support company growth of 25%;

  Maintained work flow through 48 CNC machine production facility as well as directed receiving, in-process and final inspection areas equipped with Coordinate Measuring Machines, Optical Comparators, Surface Plates and related tools;

  Authorized rework and process changes, while assuring staff was trained on inspection techniques and blueprint reading.

 

 

Earlier Experience

 

- Quality Supervisor, Medical Lab Automation                                                               

 

- Quality and Shipping Supervisor, Cavitron Ultrasonics                                                                                    

 

- Quality Control Inspector, Union Carbide Clinical Diagnostics                                                              

 

- Specialist Fourth Class, U.S. Army (Honorable Discharge)

 

Specialized Training Credentials

 

n Coursework C  Geometric Dimension and Tolerancing, American National Standards Intitute,  ISO 0000 xxxxxx xxxx , xxxx , xxxxx 00000 by UL and Excel; GMP by Regulatory Affairs Professional Society and FDA; Internal Auditing; Gage Calibration; Electronic Records and Signatures, (21 CFR Part 11); Restricted Substances Compliance, (RoHS and WEEE); In Vitro Diagnostics Directive, IVDD 98/79 EC.

 

 

Professional Affiliations

 

- Memberships: American Society for Quality, Association for the Advancement of Medical Instrumentation, Regulatory Affairs Professional Society

 

 

 

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