Rudolph Dizon

Menlo Park, CA *****

510-***-****

ad1msc@r.postjobfree.com

HIGHLIGHTS OF QUALIFICATIONS

Quality focused, diversified professional with 7+ years in an FDA regulated environment. Expertise in Customer Complaints, Quality Systems Administration

Excellent communication and interpersonal skills and a proven ability to juggle multiple high priority tasks

Detail oriented, with a reputation for thorough process documentation creation, review, and training

Experienced in Electronic Management Systems

PROFESSIONAL EXPERIENCE:

labcorp

Quality analyst/document control coordinator

apr 2023 – dec 2023 (temp/contract)

Management and continuous improvement of Monogram’s Quality Management System

Independently executes paper batch record reviews and collaborates within manufacturing to resolve discrepancies or errors as it relates to good documentation practices.

Perform Quality reviews of various documentation for inspection and release and ensure compliance to cGMPs.

Assists in the activities related to document control such as number issuance to reviewing and approving, collecting of signatures, closing and releasing of documents

Investigate non conformances, quality incidents, customer complaints and deviations

Assist and provide support for internal and external audit, coordination with other functions to obtain documents and records during audits and inspection

verily/google life sciences

Quality assurance/regulatory affairs coordinator

mar 2022 – apr 2023

Collaborate across multi functional groups, perform QA and Regulatory review of clinical study protocols, and various other documentation and assess for impact on Regulatory, Quality Systems, Adverse events, and support for clinical trials documentations

Support Regulatory Affairs in assigned projects, preparation and maintenance of product technical files for CE marking, organize, prepare and maintain documents for product submissions

Responsible for supporting Post Market Surveillance activities associated with customer complaint management and adverse event reporting assessments

Complete and submit Vigilance reports, MDR and any other country specific regulatory reporting documents

Assist with review of non conforming events, perform root cause assessment and investigate quality incidents

Perform the QA document control function in QA, including managing document workflows, tracking and processing approval, distributing and archiving documents/records with overall responsibility for document control processes

Support regulatory registration for global product registration activities

Assist Regulatory team in the update, improvement and creation of internal policies and procedures

Keep abreast of new or changed regulations, guidance documents and standards in the markets/regions and communicate to Regulatory team

carl zeiss meditech (zeiss medical technology)

quality assurance specialist, client services rep

jan 2021 – Feb 2022 (contract)

Record and evaluate complaint submissions. Record and provide regulatory reportability decisions on complaints

Communicate with territory managers and clinical specialists to acquire relevant complaint information.

Respond to inquiries regarding medical device report submissions associated with device malfunction or serious injury

Interface with Third Party Manufacturers, health care professionals, general public, internal customers

Prepare and submits Mandatory Problem Reports for review in a timely manner.

Submit vigilance report and files preliminary and final MPRs with Health Canada, US FDA and other international regulatory bodies

Maintains the QA Complaints Document Archive and active Quality System files in an inspection ready state

becton dickinson & Company - bd medical

QA specialist 2, CLinical complaints

apr 2020 – dec 2021 (Contract)

Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability

Coordinate with BD MMS complaint handling sites to ensure consistency in complaint records and implements solutions and process efficiencies

Conduct customer outreach regarding complaint information received, coordinate product return and verify complaint receipt in CRM

Assess complaint for determination of vigilance and/or adverse event reporting for US, Canada, and EU

Prepare and submit USFDA Medwatch, Health Canada (MDPR), EU MDV reports

Management and maintenance of complaint handling procedures, including processing and technical editing of QA controlled documents

Validant consulting

Olympus surgical technologies america

market quality specialist, customer services

may 2019 – feb 2020 (Contract)

Support client in post market complaint temporary remediation project with focus on closing a backlog of aging complaints

Responsible for the customer complaint handling process, reviewing complaints and performing assessments to determine potential reportability, assignment of investigation, coordination of investigation results and complaint closure.

Conduct customer outreach to obtain and verify complaint information, process and record complaint information in SalesForce

Identify complaints that require MDR revision based on new information that require supplemental report to FDA based on new information.

Complete and submit MDRs/Vigilance/MedWatch reports for each reported complaint, US (FDA), and International worldwide regulations

Becton, dickinson & company

bd biosciences

quality assurance specialist, customer complaints coordinator

Jul 2015 – feb 2019

Manage the process of the complaint handling system including, receipt of complaints from all sources

Checking for complaint accuracy and content, correct information to process the complaint in CRM

Review product investigations for completeness and to establish root cause as required

Responsible for global medical device reporting, ensure Medical Device Vigilance reporting in accordance with 21CFR803 MDR and EU Vigilance Reporting regulations

Serve as the main resource for the QA team and/or subject matter expert on complaints

Assist with writing or reviewing customer closure letters prior to closing complaint file

Assist with and respond to internal and external audits and inspections

Perform other quality and regulatory related duties as assigned

Education:

Heald Business College, Hayward, CA – Associate in Applied Sciences, Medical Assisting, October 2010

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