|
|
Title: |
Quality Manager
|
Location: |
US-California-Los Angeles
|
Work History: |
From: Herbert Fabian
Attn: H.R. Representative
Dear Sir / Madam
Enclosed you will find my resume which describes my most recent experiences in my areas of expertise. At this time I am looking forward to an interview with a company that is looking for a candidate with the experience and background as to what I present on my resume.
My experience expands with over ten years in the Quality Assurance and Quality Control areas in the medical device industry, but also I have other areas of expertise that include Purchasing Management, Safety, Regulatory Affairs (Federal, State, and County), Plating Manager and Special Projects Coordinator. Besides I have also experience in dealing and procuring documents for international markets for the export and distribution of products that are regulated under government’s legislatures, mostly those products under the FDA umbrella.
If you consider my resume to be of interest for your organizational goals, I will be glad to set up an interview at your own convenience so that we can discuss more in detail your requirements and expectations.
Sincerely yours,
Herbert Fabian
Home: 818-424-0737
Cell: 281-599-0027
Herbert Fabian
19315 Hickory Meadow Ln
Houston, TX 77084
Home: 818-424-0737
Cell: 281-599-0027
Hfglendale@aol.com
Objective: Manufacturing Quality Assurance Manager
Education: National University Los Angeles, CA
Master Degree
• Business Administration
West Coast University Los Angeles, CA
Bachelor Degree
• Industrial Technology
Professional
Experience: 2001-2007 QuadrTech Corp Gardena, CA
Quality Assurance Manager /
Medical devices (earrings and ear piercing devices) mfg.
• Design and implementation of quality program GMP’s/SPC/FDA contact.
• Implementation of ISO 13485 - standard for medical devices.
• Implementation of ISO 14971- Standard for Risk Management.
• Certified ISO auditor for ISO 13485 provided by EMERGO
• Administration of the Quality Assurance Program (sterilization & validations)
• Cooperate, advise, and coordinate all matters affecting the quality of
the process, manufacturing procedures and final product.
• Procure and facilitate Maquiladora operations in Mexico
• Q.C. Manager for manufacturing facility (maquiladora) in Mexico
• Have final authority for the rejection of acceptance of all products
• Participate in problem solving / Technical Files / DHF
• Control of CAPA documentation and procedures
• Training of outside sources
• Work in the design and implementation of packaging configurations prior to sterilization.
• Assist in the development of OTC solutions, finding the best suitable filling houses, conducting and assisting the validation of these outside sources.
• Supervising and directing microbiological analysis.
• Perform process validations and equipment qualifications as required (sealing equipment, plating equipment, labeling equipment).
• Analyze final product for safe human use.
• Management of Inspection personnel.
• Procuring FDA certificates for EXPORTS and DISTRIBUTION of medical devices
• Safety Manager – Contact for OSHA and other city and state agencies / designed Safety Manual. – Reports and Audits responsibility.
• Purchasing Supervisor – Approving all Purchasing Orders / procuring materials and equipment / contact for suppliers and vendor trainer / Negotiate Prices / Analyze production inventory/ finding best suitable facilities for OTC processes.
• Environmental and Regulatory Contact for the County and State
Herbert Fabian
(continued)
• Special Projects Coordinator / procuring Export Certificates
• Plating Department Supervisor for Metal Parts Monitoring the quality and composition of all metals used for manufacturing. Chemical processes and procurement, supervise and training on plating process (safety, process, training).
1999-2001 Parter Medical Services Carson, CA
Quality Assurance Supervisor / Mgr.
Sterilization Contractor for Medical Devices
• Approve and verify documentation for customers.
• Verify that “DEVIATIONS” were not omitted.
• Receiving of products for customer’s ETO process and requirements
• Supervise products from Pre-Conditioning – Sterilization - Aeration.
• Team member in the development and implementation of ISO 9002
• Perform Quality Audits as assigned.
• Review sterilization processes, protocols and validations.
• Apply SPC when required - validations
• Apply OSHA’s regulations throughout the process (safety)
• Assist customers with scheduling sterilized loads
• Operation of sterilization chambers
1994-1999 (closed down) Basset Furniture Corp. Los Angeles, CA
Regional Quality Control Manager /
Bedding Division
Furniture Manufacturer (Cut and Sew Department – Assembly Dept)
• Design quality control procedures for the assembly department (Mfg)
• Contact for all quality issues in the West Coast
• Provide training on all quality function and manufacturing procedures.
• Safety Coordinator / Quality Auditor
1984-1993 (closed down) Polamedco Inc. Los Angeles, CA
Quality Assurance Supervisor/Manager /
Medical Devices mfg. (Endotracheal Tubes Mfg. / Catheters)
• Design manual for GMP’s and QA
• Liaison for all FDA’s affairs.
• Testing and inspection of raw materials and final product
• Design validations and re-validations for products.
• Train employees on all GMP’s procedures.
• Monitoring of all microbiological testing procedures.
• Assist manufacturing in the areas of “Quality, Process, Safety”
• R&D Coordinator
• Purchasing Supervisor – Audit and approve outside suppliers, - Approve Purchase orders.
Herbert Fabian
Languages: Fluidity with Spanish, verbal, written and reading
Computer
Knowledge: Excel / MS Word / Outlook / Power Point
References: Hormoz Foroughi 310-327-4417
Manager at Parter Medical Products
Fred Safford 310-851-6161
Corporate Attorney
Herbert Fabian
Areas under Control:
Quality Assurance Mgr:
1 Scheduling
2 Sterilization Process
3 Documentation
4 Lab Analysis And Interpretation
5 Revalidations And Modifications
6 FDA Contact
7 Customer’s Complaint
Purchasing Supervisor:
1 Process Purchase Orders
2 Negotiate Prices
3 Search For Outside Sources On A Competitive Basis
4 Visiting And Training Outside Sources
5 Solve Billing Discrepancies
6 Verify Inventories
7 Solve Quality Discrepancies (Received Products)
Safety Mgr:
1 Design Safety Manual And Procedures
2 Follow Up On Injuries And Treatments
3 Training
4 OSHA’s Contact
5 Filing Of Annual Reports For The State
6 MSDS’s Control And Education
Regulatory Affairs:
1 Disposal Of Chemicals
2 Control Of Chemicals
3 Water Compliance For The County
4 Fire Department Contact
5 International Certificates For Export And Distribution
6 Letters For Foreign Governments (Health Dept)
7 Transportation Permits For Facility In Mexico (NAFTA)
Plating Dept. Mgr:
1 Purchase Of Controlled Chemicals
2 Design And Purchase Of Plating Stations
3 Training And Research for Different Processes (chemical)
4 Safety And Environmental Program Coordination
Special Projects Coordinator:
1 Packaging Equipment, Sterilization Configurations plus Miscellaneous Projects in other areas.
|
Skills: |
Professional
Experience: 2001-2007 QuadrTech Corp Gardena, CA
Quality Assurance Manager /
Medical devices (earrings and ear piercing devices) mfg.
• Design and implementation of quality program GMP’s/SPC/FDA contact.
• Implementation of ISO 13485 - standard for medical devices.
• Implementation of ISO 14971- Standard for Risk Management.
• Certified ISO auditor for ISO 13485 provided by EMERGO
• Administration of the Quality Assurance Program (sterilization & validations)
• Cooperate, advise, and coordinate all matters affecting the quality of
the process, manufacturing procedures and final product.
• Procure and facilitate Maquiladora operations in Mexico
• Q.C. Manager for manufacturing facility (maquiladora) in Mexico
• Have final authority for the rejection of acceptance of all products
• Participate in problem solving / Technical Files / DHF
• Control of CAPA documentation and procedures
• Training of outside sources
• Work in the design and implementation of packaging configurations prior to sterilization.
• Assist in the development of OTC solutions, finding the best suitable filling houses, conducting and assisting the validation of these outside sources.
• Supervising and directing microbiological analysis.
• Perform process validations and equipment qualifications as required (sealing equipment, plating equipment, labeling equipment).
• Analyze final product for safe human use.
• Management of Inspection personnel.
• Procuring FDA certificates for EXPORTS and DISTRIBUTION of medical devices
• Safety Manager – Contact for OSHA and other city and state agencies / designed Safety Manual. – Reports and Audits responsibility.
• Purchasing Supervisor – Approving all Purchasing Orders / procuring materials and equipment / contact for suppliers and vendor trainer / Negotiate Prices / Analyze production inventory/ finding best suitable facilities for OTC processes.
• Environmental and Regulatory Contact for the County and State
Herbert Fabian
(continued)
• Special Projects Coordinator / procuring Export Certificates
• Plating Department Supervisor for Metal Parts Monitoring the quality and composition of all metals used for manufacturing. Chemical processes and procurement, supervise and training on plating process (safety, process, training).
1999-2001 Parter Medical Services Carson, CA
Quality Assurance Supervisor / Mgr.
Sterilization Contractor for Medical Devices
• Approve and verify documentation for customers.
• Verify that “DEVIATIONS” were not omitted.
• Receiving of products for customer’s ETO process and requirements
• Supervise products from Pre-Conditioning – Sterilization - Aeration.
• Team member in the development and implementation of ISO 9002
• Perform Quality Audits as assigned.
• Review sterilization processes, protocols and validations.
• Apply SPC when required - validations
• Apply OSHA’s regulations throughout the process (safety)
• Assist customers with scheduling sterilized loads
• Operation of sterilization chambers
1994-1999 (closed down) Basset Furniture Corp. Los Angeles, CA
Regional Quality Control Manager /
Bedding Division
Furniture Manufacturer (Cut and Sew Department – Assembly Dept)
• Design quality control procedures for the assembly department (Mfg)
• Contact for all quality issues in the West Coast
• Provide training on all quality function and manufacturing procedures.
• Safety Coordinator / Quality Auditor
1984-1993 (closed down) Polamedco Inc. Los Angeles, CA
Quality Assurance Supervisor/Manager /
Medical Devices mfg. (Endotracheal Tubes Mfg. / Catheters)
• Design manual for GMP’s and QA
• Liaison for all FDA’s affairs.
• Testing and inspection of raw materials and final product
• Design validations and re-validations for products.
• Train employees on all GMP’s procedures.
• Monitoring of all microbiological testing procedures.
• Assist manufacturing in the areas of “Quality, Process, Safety”
• R&D Coordinator
• Purchasing Supervisor – Audit and approve outside suppliers, - Approve Purchase orders.
|
Education: |
Education: National University Los Angeles, CA
Master Degree
• Business Administration
West Coast University Los Angeles, CA
Bachelor Degree
• Industrial Technology
|
Top People Endorsing Herbert
Herbert has received 0 endorsements.
click here to view all of the Members endorsing Herbert |
| |
Rank |
Title |
Location |
Details |
No endorsements.
|
|
Top People Herbert Endorses
Herbert has endorsed 0 Members.
click here to view all of the Members Herbert has endorsed |
| |
Rank |
Title |
Location |
Details |
None.
|
|
Recent Public Messages sent to Herbert
|
| From |
Date |
Message |
No public messages. |
|
|
