Isaac Akoto Bamfo

Supplier Summary

●Issac has an experience in document management and ensure compliance of audit records and quality documents.

●Reviewed and approve controlled quality documents for compliance and adherence to process and system requirements.

●Created and revised process-controlled quality documents.

●Performed work statement, QC/CSP, auditing, developed reports and tracked measurements as assigned by the Quality Manager

●Skilled in using ERP Systems.(Epicor, Medtrack, Winspc, OEM Buddy etc)

●Performed day-to-day activities with department applications such Microsoft Office, audit work paper software, audit command language and uses standard department templates and processes for performing audits.

●Exercised excellent PC skills using Microsoft Outlook, Word and Excel required

●ERP or MRP experience practiced

●He is interested and available for an interview ASAP.

Professional Summary

●Experienced in Quality Assurance Inspector with 6 years of experience leading QA departments and

strengthen the overall corporation through knowledge and attention to detail.

●Performs daily process quality checks using Performance Evaluations criteria.

●Performed audits and developed reports and tracked measurements as assigned by the Quality Manager.

●Well-versed experience with CAPA management and GMP Regulations.

●Experience in developing, deploying, implementing, and monitoring Documented Quality Management Systems in projects of similar scale and complexity.

Education

●Bachelor of Computer Science, Kwame Nkrumah University of Science and Technology, Ghana 2009

Certifications

●Google IT Support

Skills

●Experience working in a regulated quality environment required

●Experience using gauges and tools to measure part dimensions and compare to prints required

●Experience with CAPA (corrective and preventative actions) required

●Ability to work in the office full time required

●Excellent PC skills using Microsoft Outlook, Word, and Excel required

●ERP or MRP experience preferred

●Experience QSR or ISO 13485 Medical Device Regulation experience a plus

●Management

●Inspection

●Packaging

●Great skill set in System Troubleshooting and software management

●Adobe Creative Suite skill set

●Skilled in using ERP Systems.(Epicor, Medtrack, Winspc, OEM Buddy etc)

●IT auditing

●Computer Networking

Professional Experience

Cardiofocus Inc. May 2021 – Jun 2022

Assembler and Quality Inspector/Auditor

●Performed daily process quality checks using performance evaluations criteria of the DDJF

●Performance Work Statement, QC/CSP.

●Performed document management and ensure compliance of audit records and quality documents.

●Reviewed and approve controlled quality documents for compliance and adherence to process and system requirements.

●Created and revised process-controlled quality documents.

●Performed audits and developed reports and tracked measurements as assigned by the Quality Manager

●Assisted and supported the Quality Manager to ensure that all products and services meet Mistras’ established

standard of quality.

●Performed such individual assignments as management may direct performed warranty reviews and provide technical knowledge to warranty decision-making activities.

●Performed all establish safe working procedures.

●Assisted with the development and implementation of security policies, standards, and education efforts.

●Assisted in updating the risk & control matrix for each engagement with oversight from the Managers and other Audit leadership.

●Assisted in completing work-papers on time, and organizes evidence to fully support conclusions and findings.

●Performed day-to-day activities with department applications such Microsoft Office, Audit Work paper Software, Audit Command Language and uses standard department templates and processes for performing audits.

●Collaborated with the Corporate Information Security and IT Audit teams to review Information Security Policies, standards, procedures, and guidelines.

Insulet Corporation Jan 2018 – Feb 2021

Quality Inspector/ Team Lead/ Supervisor

●Capable of planning and coordinating the activities of others with excellent communication and interpersonal skills essential

●Previous supervisory responsibility with demonstrated leadership and team-building skills

●Performed document management and ensure compliance of audit records and quality documents.

●Reviewed and approve controlled quality documents for compliance and adherence to process and system requirements.

●Created and revised process-controlled quality documents.

●Good command of written and spoken English, Strong oral communication skills

●Proven people skills with the ability to lead and guide a team as well as establish and maintain a solid customer

Interface

●Proven experience in developing, deploying, implementing, and monitoring documented quality management systems in projects of similar scale and complexity

●Had demonstrated strong engineering competence

●Self-starter with good organizational and problem-solving skills

Web Industries Jan 2015-Dec 2018

Quality Inspector /Assembler/Team Lead

●Lead and supervised 8 personnel in conducting inspections

●Maintained an industry standard of quality assurance through regular training and on-site consultation

●Lowered rework 33% by actively participating in client projects with less-experienced technicians

●Performed document management and ensure compliance of audit records and quality documents.

●Reviewed and approve controlled quality documents for compliance and adherence to process and system requirements.

●Created and revised process-controlled quality documents.

●Maintained certification records on all quality assurance department staff with regular testing and training

●Worked in a regulated quality environment

●Used gauges and tools to measure part dimensions and compare them to prints

●Used CAPA (corrective and preventative actions)

●Exercised excellent PC skills using Microsoft Outlook, Word and Excel required

●ERP or MRP experience practiced

●Used QSR or ISO 13485 Medical Device Regulation.

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