Solomon Chen

Solomon Chen Email and Phone Number

Manager, QA/RA at A Plus International Inc. @ A Plus International Inc.
5138 Eucalyptus Avenue, Chino,California 91710,United States
Solomon Chen's Location
Chino Hills, California, United States, United States
Solomon Chen's Contact Details

Solomon Chen personal email

n/a
About Solomon Chen

Over 30 years of extensive experience in disposable medical device manufacturing, quality assurance and regulatory affairs. Responsible for filing successful 510(K) Submissions to the FDA. Lead teams from different manufacturing facilities through many FDA Inspections in the USA and abroad. Lead quality engineers to develop sterilization cycles and conduct validations for different sterilization methods such as ETO, Gamma Irradiation and Steam Sterilizations. Worked with Fortune 500 Medical Device firms on external manufacturing projects.

Solomon Chen's Current Company Details
A Plus International Inc.

A Plus International Inc.

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Manager, QA/RA at A Plus International Inc.
5138 Eucalyptus Avenue, Chino,California 91710,United States
Website:
aplusgroup.net
Employees:
38
Solomon Chen Work Experience Details
  • A Plus International Inc.
    Manager, Quality Assurance And Regulatory Affairs
    A Plus International Inc. Oct 1998 - Present
    Oversees the quality assurance systems and regulatory compliance for the firm’s headquarter in the USA and 10+ overseas manufacturing facilities. A Plus International Inc. provides ODM and OEM services to Fortune 500 Medical Device firms.
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  • A Plus International Inc.
    Quality Engineer
    A Plus International Inc. Oct 1993 - Oct 1998
    Designed, sourced & installed testing equipment and trained personnel for in-house laboratories at overseas manufacturing facilities to conduct tests according to U.S. Pharmacopeia, ASTM, AATCC...etc. Standards. Maintain complaint and MDR file documentation in accordance with regulatory requirements. Complete global complaint handling and adverse event reporting activities related to our products. Lead CAPA efforts to resolve quality issues. Conduct proces validations and equipment qualifications.
  • Fda Us Agent
    Fda Us Agent For Foreign Medical Device Establishments
    Fda Us Agent Oct 1998 - Present
    Act as US Agents for foreign medical device establishments for the US FDA. Clients include several leading sterilization contractors (EtO, Gamma & E-beam) in China. Provide regutatory compliance consultations to these firms.

Solomon Chen Skills

R&d Fda Iso Key Account Management International Sales Quality System Design Control Root Cause Analysis Gmp 21 Cfr Part 11 Regulatory Affairs Biotechnology Capa Quality Assurance Iso 14971 Iso 13485 Sop Medical Devices Cqe Validation Pharmaceutical Industry Quality Management Product Development Ce Marking Quality Auditing Change Control Corrective And Preventive Action U.s. Food And Drug Administration

Solomon Chen Education Details

  • University Of California, Riverside
    University Of California, Riverside
    Biochemistry

Frequently Asked Questions about Solomon Chen

What company does Solomon Chen work for?

Solomon Chen works for A Plus International Inc.

What is Solomon Chen's role at the current company?

Solomon Chen's current role is Manager, QA/RA at A Plus International Inc..

What is Solomon Chen's email address?

Solomon Chen's email address is so****@****oup.net

What schools did Solomon Chen attend?

Solomon Chen attended University Of California, Riverside.

What skills is Solomon Chen known for?

Solomon Chen has skills like R&d, Fda, Iso, Key Account Management, International Sales, Quality System, Design Control, Root Cause Analysis, Gmp, 21 Cfr Part 11, Regulatory Affairs, Biotechnology.

Who are Solomon Chen's colleagues?

Solomon Chen's colleagues are Olivia Tavares, Weiliang Xian, Ella Yu, Maya Moumene, Kyanna Plazola, Kelly Lin.

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