Noor Rahman Zazai
QA /QC Lead
Middletown,CT
Summary
I am a motivated multi-lingual American with full and legal work authorization in the United States. I have a great work ethic and I am Interested to learn new skills. I have over 7 years of experience as a QC and QA Manager, IT Support, Software Engineer in test and Linguist /Translator also very good at adjusting to a new environment also I am a current employee of Randstad working as machine operator for Medtronic - Mars building.
Overview
2026
2026
years of professional experience
19
19
years of post-secondary education
5
5
Languages
Work History
QA Team Manager
Medtronic
09.2021 - Current
- Lead and oversee the implementation and maintenance of ISO 13485 and FDA 21 CFR Part 820-compliant quality systems across manufacturing operations.
- Develop, manage, and continuously improve the Quality Management System (QMS), ensuring full compliance with global regulatory requirements.
- Supervise and mentor QA and QC teams, ensuring inspection processes, documentation, and quality standards are consistently met.
- Manage internal and external audits, including FDA inspections, ISO audits, and customer quality visits; lead audit readiness and response planning.
- Oversee the handling of non-conformances (NCRs) and lead root cause investigations and Corrective and Preventive Actions (CAPA) processes.
- Ensure validation of manufacturing processes, equipment, and cleaning procedures in accordance with regulatory and internal standards.
- Review and approve batch records, validation protocols, quality reports, and standard operating procedures (SOPs).
- Collaborate with R&D and engineering to ensure new product introductions meet quality requirements from design through production.
- Drive continuous improvement initiatives to reduce scrap, improve yield, and enhance overall product quality.
- Monitor key quality performance indicators (KPIs) and report trends to upper management.
- Maintain training programs to ensure all employees are compliant with GMP and quality standards.
- Evaluated employee performance and coached and trained team members, increasing quality of work and employee motivation.
- Led employee relations through effective communication, coaching, training, and development.
Quality Control
Medtronic
- Performed visual and dimensional inspections of hypodermic needles to ensure compliance with ISO 13485 and FDA regulations.
- Used precision instruments such as microscopes, micrometers, and calipers to check needle sharpness, diameter, length, and bevel angle.
- Conducted in-process and final product inspections to detect surface defects, burrs, or contamination.
- Documented inspection results, non-conformances, and test outcomes using QMS and batch record systems.
- Collaborated with production and quality assurance teams to investigate defects and assist with root cause analysis (RCA).
- Executed functional tests including penetration force and flow rate testing based on product type.
- Ensured adherence to cleanroom protocols and sterility requirements during inspection and packaging processes.
- Supported internal and external audits by providing detailed records and inspection reports.
- Calibrated and maintained inspection tools and equipment on a regular basis.
- Participated in continuous improvement initiatives to enhance product quality and reduce scrap rates.
- Maintained statistical quality control program for laboratory.
- Reduced shipping errors with diligent quality control checks of outgoing packages.
Machine Operator
Medtronic
- Followed detailed instructions to operate machines with accuracy and produce quality products.
- Loaded raw materials into machines and unloaded finished products to keep manufacturing process running smoothly.
- Set up and adjusted equipment and properly configured machines for daily operation.
- Set up and ran machinery to produce exceptional products for industrial needs.
Assembler
Randstad
- Increased production efficiency by assembling components quickly and accurately.
- Maintained high-quality standards with thorough inspections of assembled parts.
- Enhanced workplace safety by maintaining a clean and organized work area at all times.
- Demonstrated flexibility in adapting to various types of assemblies, allowing for seamless transition between different projects as needed.
English Language Linguist/Translator
Mission Essential Personnel (MEP)
03.2019 - 04.2021
- Translated / Interpreted Information Communication Technology Related Documents.
- Acted as a translator for various individuals on staff.
- Converted documents and other company materials into the desired language to submit to management for approval.
- Provided personalized tutoring sessions for individualized attention and accelerated progress.
- Enhanced language proficiency by designing and implementing tailored lesson plans for diverse student groups.
Information Communication Support (IT Support)
Global Technology
02.2018 - 11.2018
- Maintenance of the mailing system.
- Configuration of CISCO routers, switches, firewalls, and VPN connections.
- Diagnosing Hardware and Software Problems, Performed Data Backup and disaster recovery.
- Inventory of emergency repairs, testing computer hardware and software on the Client machines, troubleshooting malfunction of network hardware and software applications, telephone and security system for the client.
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
Education
Certification in Science -
Operations Management
Kabul Afghanistan 01.2020 - 01.2021
Bachelor's Degree - Computer Science
Jahan University
Kabul Afghanistan 01.2016 - 01.2020
English Language Diploma -
Muslim English Institute
Kabul Afghanistan 01.2016 - 01.2018
High School Diploma -
Said Noor Mohammad Shah Mina High School
Kabul Afghanistan 01.2004 - 01.2016
Skills
Quality Assurance & Regulatory Standards
- ISO 13485 & FDA 21 CFR Part 820 Compliance
- Quality Management System (QMS) Development
- Non-Conformance (NCR) & CAPA Management
- Internal & External Audit Readiness (FDA, ISO)
- Batch Record Review & SOP Approval
- GMP & Cleanroom Protocol Adherence
- Root Cause Analysis (RCA) & Continuous Improvement
Quality Control & Manufacturing Operations
- Machine Operation & Adjustment (Flex, CV & KV Needle Manufacturing)
- Visual & Dimensional Product Inspection
- Equipment Validation & Maintenance
- In-Process & Final Product Inspection
- Scrap Reduction & Yield Improvement
- Penetration Force & Flow Rate Testing
- Team Leadership & Staff Mentoring
- KPI Monitoring & Performance Reporting
- Shift Scheduling & Labor Planning
- Cross-Functional Collaboration
- Conflict Resolution & Communication
- Training & Onboarding New Staff
Timeline
QA Team Manager
Medtronic
09.2021 - Current
Certification in Science -
Operations Management
01.2020 - 01.2021
English Language Linguist/Translator
Mission Essential Personnel (MEP)
03.2019 - 04.2021
Information Communication Support (IT Support)
Global Technology
02.2018 - 11.2018
Bachelor's Degree - Computer Science
Jahan University
01.2016 - 01.2020
English Language Diploma -
Muslim English Institute
01.2016 - 01.2018
High School Diploma -
Said Noor Mohammad Shah Mina High School
01.2004 - 01.2016
Quality Control
Medtronic
Machine Operator
Medtronic
Assembler
Randstad
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