Rawal Waseem
Sligo
Summary
Experienced Quality Engineer with a strong aptitude for identifying risks and implementing actionable initiatives to improve quality. Adept at creating and implementing quality strategy and supervising inspections to foster conformance to company standards. Dedicated and energetic with a proven history of implementing corrective actions to drive quality and improve efficiency.
Overview
7
7
years of professional experience
Work History
Quality Engineer
Arrotek Medical
Sligo, Ireland
05.2022 - Current
- Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products.
- Assist with the confirmation that corrective measures meet acceptable reliability standards, and that documentation is complete and compliant with requirements.
- Issue of product paperwork/batch records to manufacture, and also review and release of the same, and compile COA, COC.
- Approval of change requests for product, process, and quality changes. Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects, and change notices.
- Preparing and updating operations procedures and associated documentation.
- Manage environmental monitoring and calibration metrics, and ensure they are completed on a monthly basis.
- Quality review of responsible area validation documentation.
- Performing an active role in further development and continuous improvement of the QMS.
- Liaise with suppliers and customers on quality-related issues.
- Assist the Head of Quality in implementing and maintaining the QMS.
- Conduct internal audits, including closing out audits in a timely manner, creating audit finding reports, and determining proper corrective and preventive actions.
- Create, maintain, and issue company quality documentation, such as SOPs and WIs.
- Support customer and surveillance accredited audits.
- Provide monthly and quarterly metrics regarding quality for management reviews.
- Maintains a safe and healthy work environment by following standards and procedures, and complying with legal regulations.
- Updates job knowledge by participating in educational opportunities.
- Ensure compliance with all applicable regulatory standards and cGMP procedures.
Quality Technician
Phillips Medisize
03.2021 - 05.2022
- Integrated and became a vital member of a cross functional team (CFT) involved in the provision of support and compliant oversight w.r.t Quality, and generation of required documentation and the update & upkeep of the electronic QMS (SAP)
- Utilized a self-driven approach to engaging with the cross functional teams within the site to ensure the quality system is developed and maintained in keeping pace with change implementation
- Assess & understand product requirements by reviewing product specifications (drawings) and any other customer documentation to become the basis from which to build up the quality system requirements for handover to the production value streams
- Established and maintained documentation in line with overall QMS requirements
- Assisted in the development of component specification and introducing new components and resin on site
- Identified QMS updates required as part of all activity and proactively initiated updates
- Participated in the execution of validations to provide guidance & support to those executing on the validations, answering any questions that may arise
- Carried out training on Protocols if required
- Provided clear guidance on questions relating to product quality, and interpretation of specifications
- Processed any Quality Notification/NCMRs associated with validation or verification runs, working with the CFT to process the QN to a closure
- Utilized different aspects of the QMS to support any other event occurrences that may arise, e.g
- Deviation Request, Risk Assessment
- Provided vital Input to the development of other processes within the QMS, e.g., process risk assessments, pFMEA, validation & verification protocol review & understanding etc
- Liaised & supported communication with customers and suppliers on new and existing projects
- Provided Quality support to other departments as part of day-to-day activities
- Ensured all tasks are performed in line with GMP & GDP requirements
- Performed process control monitoring & actively participated in improvement activities
- Reviewed and approved metrology reports, where appropriate, for batch release and validation purposes
- Supported receiving and inspection of incoming goods and materials
- Ensured that all parts / materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications
- Assisted shift personnel with quality issues and/or measurement techniques
- Performed periodic audits as requested and complete necessary documentation
- Archived quality records, samples, and procedures
- Performed batch review and final decision to release product for shipment
- Prepared and performed training as required
- Always maintained personal training status up to date
- Maintained strict adherence to all Health and Safety and Environmental requirements, and proactively contributed to the improvement of Health and Safety related systems
- Ensured all work is completed in a timely manner and in accordance with safety, quality, delivery, and cost requirements
Quality Inspector
Phillips Medisize
04.2018 - 03.2021
- Perform duties with integrity & compliance in the following of defined standard operating procedures
- Exercise flawless GMP & GDP methods
- Support the development of documentation, via creation, review of same under the guidance of subject matter experts
- Identify updates required as part of all activity and advise quality engineering
- Work closely with production supervisor and cell-based trainer
- Report any Non-conformities, directly to supervisor & operations Team
- Perform destructive testing on all in process samples collected from operatives
- Responsible for ensuring all operatives have the correct required materials for the product in question
- Collaborate with Quality Engineer/Manager to assist internal and external audits
- Conducted scheduled inspections with a high level of accuracy and efficiency
- Conducted performance tests on products to analyze usability, functions and required improvements
- Writing detailed explanations on products failing to meet quality inspection standards, submitting to operation and engineering teams for review
- Shared technical expertise and extensive knowledge of product functions with production teams and other relevant staff
- Conducted training of new QI's, sharing methods of quality control and how to perform required tasks effectively and efficiently
- Read engineering schematics to compare with finished products, ensuring products matched drawing requirements
- Used excellent problem-solving and analytical thinking to resolve quality-related issues under tight deadlines
- Maintained in-depth product testing records, ensuring accurate data including written and electronic was inputted and stored correctly
- Undertook product identification and traceability activities
- Worked closely with quality engineer/manager to resolve inspection and answer material questions
- Aided in material set up in SAP such as processing notifications and inspection codes
- Provided vital feedback on customer complaints and liaised with engineering and operation teams to perform root cause analyses and performed tasks to complete CAPAs and Quality notifications.
Production Operative
Phillips Medisize
Sligo
08.2017 - 03.2018
- Experience in carrying out operations such as bonding, testing and final packaging
- Experience of working in a manufacturing cleanroom environment
- Experience of practicing immaculate GMP and GDP
- Carried out assembly activities for all products as per production schedules
- Carried out quality testing of the products with great attention to detail
- Participated in all the training requirements within the company
- Packaged and labelled items within tight deadlines, completing without assistance or supervision
- Gained experience in working under pressure to deliver optimum outcomes
- Closely monitored operations to ensure compliance with health and safety regulations
- Created boxes for shipments using cardboard and tape, completing within tight deadlines
- Conducted inspections and performance tests on faulty equipment to determine repairs required
- Ensured production areas stayed clean and obstacle-free by monitoring operations continuously
- Maintained excellent team relationships by helping others with complex tasks including machine repairing, deep cleaning and troubleshooting
- Stayed in-line with health and safety standards by closely monitoring operations and wearing personal protective equipment throughout jobs.
Education
Bachelor of Science, Level 8 - Medical biotechnology
Institute of Technology Sligo
Sligo Ireland05.2018
Level 7 - Biomedical science
Institute of Technology
Sligo Ireland05.2017
Skills
- Microsoft Office
- Strong interpersonal skills
- SAP
- Inspection reports
- Failure Investigation and Analysis
- Root Cause Analysis
- Regulatory Compliance
- Corrective Action Planning
- Non-conformance processes
- SOP Development
- Process Validation
- Performance Metrics
- Excellent attention to detail in oral & written communication
- Strong desire with ability to learn new processes quickly
- Takes satisfaction from having responsibility of executing the role, with a right first-time mentality
- Flexible attitude
- Excellent work ethic and commitment
- Strong ability to use own initiative, to self-motivate
- Ability to communicate effectively with all levels of employees
- Knowledge of ISO 13485 and 14971 standards
- Procedure development
- Root cause identification
- Countering Non-conformance
- Processing Non-conformance through SAP
- Initiation of CAPAs, pFMEA
- Excellent attention to detail and accuracy
- Problem-solving capabilities
Accomplishments
- Completed Lead Auditor Course from SQT.
- Completed Calibrations Course from SQT.
- Completed Environmental monitoring course.
- Completed Validations and qualified a new Cleanroom.
- Worked effectively within a team to achieve results, earning recognition from upper management and financial reward.
- Promoted to quality technician due to flawless work ethic and a commitment to deliver the best as a quality Inspector.
- Promoted to quality inspector due to flawless work ethic and a commitment to deliver the best as a production operative.
- Implemented and improved a workflow for new QI's which helped them reach their full potential within weeks.
References
- Academic Referee, David Doyle, Lecturer Environmental Science, Institute of Technology Sligo, doyle.david@itsligo.ie
- Professional Referee, Oliver Mc Loughlin, Senior Quality Engineer, Phillips Medisize, Sligo, Oliver.mcloughlin@molex.com
- Professional referee, Laura Kelly, Quality Manager, Arrotek Medical, Sligo,
Affiliations
- Vice Captain of North Fermanagh Cricket Club.
- Batsman of the year award from Northwest Cricket Union 2023.
- Organized a cricket tournament to raise funds for the Kesh development charity.
Timeline
Quality Engineer
Arrotek Medical
05.2022 - Current
Quality Technician
Phillips Medisize
03.2021 - 05.2022
Quality Inspector
Phillips Medisize
04.2018 - 03.2021
Production Operative
Phillips Medisize
08.2017 - 03.2018
Bachelor of Science, Level 8 - Medical biotechnology
Institute of Technology Sligo
Level 7 - Biomedical science
Institute of Technology
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