Document Control Compliance Manager

787-***-**** · *********@*****.***

William A. Ramos Román

Summary

Compliance Manager with vast experience in the Medical Device Industry, as trained and certified in ISO 13485:2016 (Lead Auditor), ASQ Certified Quality Auditor (CQA), and CAPA Trainer. Experience managing Quality Systems, such as CAPA, Complaint, and Document Control. Experience conducting formal internal and supplier audits. Experience reviewing and approving CAPA and Complaint Investigations. Excellent troubleshooting skills, solutions driven, highly diligent, fast learning, self-motivated and innovator. Oriented to customer service and reliable with time-schedules. Ability to perform multiple tasks and maintain good interpersonal relations. Expertise in GMPs, ISO, MDSAP and current regulatory requirements. Computer literate: Word, Microsoft, Excel, and Power Point.

Experience

2013 – 2023

Abbott / St. Jude Medical

Compliance Manager

Manage all Quality Systems which includes CAPA, Complaint, Internal Audits, Document Control and Training

Review and Approve Investigations related to product nonconformances

Supervise a Group of Quality Engineers that perform CAPA and Complaints investigations. In addition of the Quality System Supervisor is responsible for Document Control, Training and Compliance. Supervise Compliance Specialist which is responsible of Internal Audits, Management Review and Trending Forums.

Responsible to Manage and assure all the compliance audits received in the facility are effectively handle including but not limited to FDA, ISO, and Corporate. Be the liaison with audit room by gathering, reviewing, and providing all the required documentation.

Responsible for the readiness of Quality Audits (including creating strategies and implementing before the audit season).

Create and Implement Strategies in Audit Observations when needed.

Ensure the compliance of the facility.

Responsible to Manage and ensure all the compliance audits received in the facility are effectively handle including but not limited to FDA, ISO, and Corporate. Be the liaison with audit room by gathering, reviewing, and providing all the required documentation. s.

Accomplishments

Responsible to Manage and ensure that all audits were more recommendations for improvements instead of observations.

Responsible for the readiness of Quality Audits, these help us with excellent results in audits (BSI audits more than 6 years without observations and one FDA audit without 483).

Responsible for opening the CAPAs related to audits and giving guidance to the engineers with the investigation.

Compliance Supervisor

Manage the Internal Audit Program

Supervise and Support the Quality Technician, Compliance Specialist and Compliance Clerk functions.

Responsible for the group that conducts internal and supplier QS regulation audits to assure compliance with Abbott requirements. Conduct failure investigations of manufacturing related issues that may impact quality or reliability of the product and determine any corrective action if required.

Responsible to assure all the compliance audits received in the facility are effectively handled including but not limited to FDA, ISO, and Corporate. Be the liaison with audit room by gathering, reviewing, and providing all the required documentation.

Handle all Puerto Rico manufacturing related complaints which include conducting DHR’s review, trending, monitoring, record keeping and assuring investigations are conducted in a timely manner. Be the liaison within the divisions’ Complaint Handling Unit.

Responsible for the CAPA system activities. Implement systems to track and follow-up data sources metrics. Responsible for updating the quality metrics by following up and gathering all the required quality information. Prepare management review data including trends, Pareto’s and gap analysis.

Assist in the investigation of product/regulatory issues by gathering and analyzing information as required.

Work on continuous improvement initiatives to improve our quality system. Must be fully conscious of the QS Regulation and ISO Standards. Provide regulatory training to the facility if required.

Ensure compliance with all SJM/Abbott procedures and all applicable regulatory agency requirements.

Accomplishments

Review all Regulatory Changes in a quarterly based to see if those changes were applicable to our facility and implement changes if applicable.

Responsible for the readiness of Quality Audits, these help us with excellent results in audits (BSI audits more than 6 years without observations and one FDA audit without 483.

Perform annually FDA Registration for both facilities of Abbott (Caguas and Arecibo).

Manage the back room for the Arecibo FDA inspection. Receiving excellent feedback from the inspector and concluding the inspection with 0 483.

Implement the MDSAP program (Medical Device Single Program) to minimize audits for the facility.

2012 – 2013

Business Excellence Consulting Inc.

Quality System Consultant (Mylan LLC, Caguas, PR)

Redesign Master Formula Sheet for manufacturing process to reduce human error, improve workflow, improve regulatory compliance, reduce redundancies and reduce nonconformance.

Aligned Manufacturing Instructions according to FDA Commitments.

Optimize Instructions according to current manufacturing process flow.

Audit Master Formula Sheets to assure commitments with FDA were included.

Support Cleaning Validation for the manufacturing equipment’s.

Quality Lead Auditor (Abbott Medical Optical, Añasco, PR)

Perform an assessment that consists in evaluating corrective and preventive actions identified in a complaint /recall CAPA and verify that were completed and effective according to the applicable regulations.

2002 – 2012

Becton and Dickinson, Caribe LTD.

Juncos, PR

Internal Auditor

Responsible for performing internal and supplier audits conducted as per Quality System Regulations (QSR), ISO standards 13485:2003, Canadian MDR, PAL and applicable regulations. Responsible of Maintaining the Internal and Supplier Audit Program.

-Conduct Internal Audits and assess that the Quality System is in compliance with the applicable regulations.

-Support QA & RC Manager in managing external audits, such as corporate and Regulatory Agencies audits.

-Oversee the development and implementation of the Supplier Audit Schedule.

-Ensure that suppliers are audited as per the corresponding procedure requirements.

-Perform supplier audits.

-Provide training and courses in QSR and ISO regulations.

-Revise investigations of Complaints, NCMR and CAPA for adequacy.

-Provide support to plant validations.

-Perform Quality System remediation plans to align systems with FDA and ISO requirements.

-Perform and Review CAPA investigations.

-Perform and Review NC investigations.

-Support the management including war room of 2012 FDA Inspection with no observation.

-e-Audit (Trackwise) Administrator.

Accomplishments

Review all Quality System Files such as CAPA, Complaints, Deviations, Management Review and Trending Meetings to ensure Good Documentation practices and see the content of the file before retention.

Responsible for the readiness of Quality Audits, these help us with excellent results in audits (BSI audits one FDA audit without 483).

Perform annually FDA Registration for both facilities of Abbott (Caguas and Arecibo).

Implement a program to audit the calibration service provider.

Certified by Becton and Dickinson to audit Sterilizers.

Quality Data Analyst

Responsible for the collection, analysis, coordination and presentation of Quality Data for compliance and management review meetings.

-Responsible for the evaluation, detection and notification of Quality System Trends or issues.

-Coordinate Quality Data Trending processes to assess effectiveness of the quality system monthly.

-Prepare and report the monthly Plant Metrics.

-Responsible for compiling data for Management Review meetings.

-Responsible for leading the Management Review meetings in a quarterly basis.

-Assure that all open compliance issues are addressed in a timely and accurate manner.

-Inform Department Managers of trends that could lead to the conclusion that a recurring event is happening and that a CAPA will be needed.

-Participate in the employee training and re-training.

-Perform Compliance Committee Meetings in a monthly basis.

-Follow up on any open action items assigned by the Compliance Committee and in the Quality Data Trending meetings.

Accomplishments

Review any Tendencies that could probably affect the product and open investigations such CAPA to resolve those tendencies before they came a nonconformity.

Environmental Quality Technician

Responsible for performing Environmental and Microbiology tests to assure the Quality of the product and of the production environment.

-Responsible for performing viable and non-viable monitoring.

-Responsible for sending samples for Bioburden and DQA Tests.

-Perform OOS investigations.

-Perform Compress Air monitoring.

-Perform Gram Stain tests.

-Responsible of updating Normal Flora Data Base

Accomplishments

Actively participate of one project related to disinfectant efficiency in the manufacturing room having the opportunity of executing the protocol of this validation.

Education

Universidad Ana G. Mendez

Gurabo, PR

BS Business Administration (Management)

Skills

Knowledge on CatsWeb System, for CAPA Investigations

Knowledge on Grand Avenue System for CAPA Investigations

Knowledge on EPIQ System for CAPA and Complaint Investigations

Knowledge on Winchill Document Management System

Knowledge of Trackwise e-CAPA and e-Audit System

Knowledge of QDMS (Quality Data Management System)

Basic Knowledge of SAP

Knowledge of Federal Regulations and Standards

Knowledge in Facility Quality System Audit Readiness

Lean Manufacturing Oriented

Fully Bilingual

Trainings and Certifications

Certified CAPA Trainer

Certified Quality Auditor (CQA)

AQS- ISO9001:2008 Lead Auditor with Medical Device Focus (ISO13485:2016) Training

BSI- ISO13485:2003 Lead Auditor (TPECS) Training

Certified Biomedical Auditor (CBA) Academy

Certified Pharmaceutical GMP Professional (CPGMP) Academy

Internal Auditor ISO 9001:2008

Sterilization and Laboratory Auditor (SALT)

Validation Tool Kit (Associate)

ASQ Member since 2011

References

Available on request

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