SUMMARY

PROFESSIONAL EXPERIENCE

ad2wcu@r.postjobfree.com

NUON TEK +44-736*-******

Proven QA expert with a successful track record in quality assurance within the Class I Medical Device manufacturing sector. Proficient in diverse database systems, ensuring streamlined data management. Known for stringent compliance with 21 CFR part 820 regulations, particularly in document control. Quick learner with strong interpersonal skills and adaptability to dynamic business environments. First Quality Retail Services

Lead Quality Assurance Technician September 2019 - September 2023 Provided on-shift leadership, prioritized tasks, assigned shifts, conducted team meetings, and managed vacation coverage. Conducted daily visual and functional testing of finished products, including analytical testing for tensile strength, dimensions, IR analysis, and particle size classification.

Validated technician device history records and performed Acceptable Quality Level (AQL) sampling to ANSI/ASQ Z1.4 standards for nonconforming products.

Prepared Certificates of Analysis for finished goods and verified COAs for incoming raw materials. Supported complaint closure process through device history record verification, confirmation testing, and inspection. Interpreted company standards when addressing nonconformance issues and inputted data into device history records. Provided quality training to employees, supported equipment calibration, and ensured compliance with Good Manufacturing Practice (GMP).

Investigated non-conformances, implemented corrective/preventive actions (CAPA), and supported internal audit preparation. Quality Assurance Technician May 2004 - September 2019 Conducted First Article/Line Clearance and routine inspections, inputting data into device history records.

Performed raw material and finished goods line clearances during product and customer changes. Collaborated with line crews and production supervisors to resolve nonconformance issues. Conducted Acceptable Quality Level (AQL) sampling to ANSI/ASQ Z1.4 standards for nonconforming products.

Supported process validations, raw material trials, and audited critical equipment performance. Validated device history records of line crews, pulled First Production Samples for customers, and assumed lead roles when needed.

Quality Assurance Manager

Quality Assurance Technician

SKILLS

Quality Systems: Proficient in formal Quality Systems, including ISO 9000, ISO 13485, and Good Manufacturing Practices (21 CFR part 820). Adaptability: Demonstrated ability to effectively manage, learn, and adapt quickly in a high-speed manufacturing environment. Analytical Skills: Expertise in interpreting complex deviations, raw material, and finished goods specifications. Complaint Management: Working knowledge of complaint management systems and device history record systems. Safety Compliance: Solid grasp of safety policies and procedures within a manufacturing setting. Quality Standards: Strong ability to follow and enforce quality and process standards. Communication: Effective communication skills, facilitating collaboration with cross-functional teams. ERP Systems: Basic knowledge of enterprise resource planning systems, including SAP and JD Edwards E1. Calibration: Experience in equipment calibration to ensure precision and accuracy. Leadership: Excellent leadership skills demonstrated through on-shift direction and team management. Time Management: First-rate time management skills, ensuring tasks are completed efficiently and within deadlines. Computer Literacy: Proficient in Microsoft Office applications; detail-oriented in documentation and reporting.