Md Karim

Master's degree in Biomedical Engineering, Bachelor's in Microbiology, minor in Chemistry, 15 years experience in quality system/quality assurance/quality control, experience in several skills including Statistical Process Control (SPC), Good Manufacturing Practice (GMP), Standard Operating Procedure (SOP), Quality System Regulation (QSR), Risk Assessment, Safety (SQF), documentation, DHR/Batch record review, Auditing – supplier, internal, and external audits, Validation/Verification of design, process, equipment, and test method.

Project

Management, Six Sigma Green Belt Certification, Standards- ISO-9001, AS9100, 13485, 14971, 17025, and FDA regulations.

Excellent computer skills: Minitab, Agile, Master Control, E1 and SAP system, Track Wise software, and Microsoft Office (PowerPoint, Excel, and Word).

QUALITY ENGINEER III - Platform aerospace - Hollywood, MD

(2026-02 - 2026-06)

• Managed Quality Management System (QMS) compliance with ISO 9001 and AS9100, ensuring organizational adherence to regulatory, customer, and internal quality requirements using TIP, Veryon, and Costpoint software.
• Wrote test procedures for the drive shaft bonding inspection, update complaints, and CAPA process.
• Performed inspections for receiving parts and during aircraft assembly processes.
• Investigated customer complaints by performing detailed root‑cause analysis, documenting findings and summaries in TIPQA, and applying statistical trending in Microsoft Excel to drive product quality, continuous improvement, and customer satisfaction.
• Led CAPA activities for issues such as false‑positive results and display malfunctions following a software update on Vanilla Aircraft (military drone) systems. Responsibilities included conducting root‑cause analysis, coordinating cross‑functional teams, implementing corrective actions, performing risk assessments, verifying effectiveness, and formally closing CAPAs.
• Improved aircraft design and manufacturing processes by implementing corrective actions aligned with ISO 9001 and AS9100 requirements, enhancing product reliability and operational performance.
• Reduced complaint volume and CAPA backlog by completing investigations and corrective actions in a timely, accurate, and effective manner.
• Issued and managed Supplier Corrective Action Requests (SCARs), ensuring supplier accountability, monitoring corrective action effectiveness, and maintaining compliance with aerospace quality standards.

QUALITY MANAGER - CooperSurgical - Gaithersburg, MD

(2025-08 - 2026-02)

(Contract)

• Managing the Quality Management System (QMS) compliance to 21 CFR part 820, ISO 13485, and EU MDR.
• Managing the packing operation and releasing products to inventory.
• Supporting the regulatory group to register CooperSurgical products in different countries.
• Perform supplier audits, issue nonconformances, work with the supplier to solve the nonconformances, and write the audit report.
• Host EU-MDR and internal audit. Answer the auditors' questions with evidence. Open CAPAs for nonconformances and complete all CAPAs related to the audit to close the audit.
• Work with the contact manufacturing company to change the process and validate the process (IQ, OQ, PQ).
• Review and approve design verification and update the drawings.
• Managing and training operating technicians to comply with QMS.

SENIOR QUALITY ENGINEER - Scanogen Inc. - Windsor Mill, MD

(2024-08 - 2025-06)

(Contract)

• Developed and implemented Quality Management System compliance to 21 CFR part 820, ISO 13485, and EU MDR.
• Wrote Quality Manual, Management Review Procedure, Product Design Development Procedure, Product Design checklist, Design Verification and Validation Procedure, Risk Management Procedure, Supplier Management Procedure, Internal and external Audit procedure, Master Validation Plan, Process validation Plan and protocol, Deviation procedure and form, and Work Instructions.
• Wrote and executed validation protocols (IQ, OQ, PQ) and reports for laser cutting and plasma treatment processes.
• Audited suppliers and managed the Approved Supplier list.

QUALITY SUPERVISOR - Integra LifeSciences - Columbia, MD

(2022-06 - 2024-06)

• Managed backroom during external and internal QMS audits, including FDA, ISO 13485, and EU MDR.
• Wrote and executed validation protocols (IQ, OQ, PQ) and reports for process (wound healing medical devices), equipment (vision system, temperature control units- freezer, refrigerator, autoclaves, and ovens), and method validations (moisture analyzer, & Differential Scanning Calorimeters) following FDA 21 CFR part 820, part 11, and ISO 13485 standards.
• Validated SIP (Steam-in-Place), CIP (Clean-in-Place), and dry heat sterilizers to ensure proper function and compliance.
• Reduced product complaints and non-conformance (NC) through risk assessment, data analysis, planning, and execution of corrective action and process improvement projects. Trackwise software was used for complaints, and Master Control software was used for NCs.
• Applied statistical analysis to determine complaint and non-conformance (NCs) trend using Minitab 18 and Microsoft Excel to drive product quality, continuous improvement, and customer satisfaction.
• Initiated and completed CAPA for manufacturing process/ QC instruments, including moisture analyzer, milling process, and environmental monitoring.
• Performed and wrote environmental monitoring performance qualification (EMPQ) for cleanrooms, based on EMPQ, updated the Environmental Monitoring (EM) SOP, including sampling maps, sampling locations, alerts, and action limits, determined maximum occupancy per cleanroom, and EM excursion compliance with ISO 14644, ISO 14698, and EN 1714 standards. Reviewed EM data and performed monthly/quarterly trending for EM excursions.

EQUIPMENT VALIDATION SPECIALIST - Emergent BioSolutions - Baltimore, MD

(2021-06 - 2022-05)

• Worked in a vaccine manufacturing facility. Led Automation projects (continuous environmental monitoring (EM) system, Formulation Filtration Pressure Monitoring System, and Flex Fill glove test system, including data integrity CFR 21-part 11 compliance) for validation and quality perspective.
• Initiated user requirements specification (URS) document and collaborated with the team members to update and approve the URS documents for the systems (continuous environmental monitoring (EM) system, Formulation Filtration Pressure Monitoring System, and Sterility test isolator glove test system).
• Performed gas assessment to verify vendor hardware, functional, and software specifications match with the URS.
• Performed and reviewed validation protocols, executed protocols, and wrote deviation and final reports.
• Performed equipment validation, including autoclave, bioreaction using Fo value, temperature mapping, and biological indicators. Performed requalification and periodic reviews for temperature and humidity control equipment.

SENIOR QUALITY ENGINEER - Abiomed - Baltimore, MD

(2019-11 - 2021-05)

• Participated in 510K submission for the OXY-1 System (oxygenates and removes carbon dioxide from blood), and the FDA approved the medical device.
• Managed change control, including initiating, executing, and tracking design, process, and supplier changes. Assessed the risk of the change regarding patient and user safety impact and updated if needed, assessed the type and extent of validation/verification required per the scope of the change, and notified customers and departments of the change.
• Performed and wrote SOPs, Work instructions (WIs), qFMEA (design failure mode and effect analysis), pFMEA (process failure mode and effect analysis), and managed DHF (design history file).
• Performed design transfer from R&D to Operations, and improved processes using 5S and lean Six Sigma tools and techniques.
• Performed control charts, np charts, process capability index (Cpk), process performance (Ppk), and data distribution to determine processes were in control (using Minitab18), performed T-test (differences between the means), and ANOVA (Analysis of Variance) to analyze design/process change impact, and the sampling size for design/process/ test method validation was determined using statistical tools.
• For incoming inspections, collaborated with the engineer to identify critical parameters per component (after the First Article was completed), created/updated incoming inspection data sheets, identified tools/equipment to measure the components, and Test Method validations were performed for those tools/ equipment as needed.
• Worked closely with the operation. If nonconformance (NC) occurred, performed investigation, risk assessment, identified root causes, performed trending using Microsoft Excel.

Master's degree - Biomedical Engineering

Bachelor's - Microbiology

Minor - Chemistry