SUMMARY

• Detail oriented Quality Engineer with extensive background in themanufacturingof medical devices and diversified innew productdevelopment.
• Experience with medical device Manufacturing, Packaging, Labelling and Quality; which includes Lean Manufacturing, Equipment/Process Validation (IQ, OQ, PQ), Test MethodValidation(TMV), Failure Mode and Effect Analysis (FMEA), Root - Cause Analysis, Corrective and Preventative Actions (CAPA) and Non-Conformance Management (NCR).
• Experience in Verification & Validation (V&V) testing, StatisticalProcess Control (SPC) and New Equipment Qualifications.
• Hands-on experience in various medicaldevicesand systems (class I, II, III), development, manufacturing, new product introduction, processvalidation, compliance/ quality/ remediation.
• Sound knowledge of ISO 13485 and FDA Quality System Regulations (21CFR 820/803/806).

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential, Ann Arbor, MI

Responsibilities:

• Performed Execution and Disposition Activities for production and supplier non-conformances (NCR's) and facilitating compliance for system launch of HLM System 1, CDI BPM, and CDI 500.
• Created and Reviewed Test Plans, Functional Specifications, Intended Use, Design Documents, IQ/OQ/PQ Test script protocols. Created FMEA & traceability matrix documentation for CDI 550 project
• Assisted cross functional teams in authoring Failure mode effect analysis and hazard analysis documentation for HLM Advanced Perfusion System 1 Roller Pumps.
• Coordinate quality initiative projects with suppliers regarding product development and manufacturing concerns and issuing supplier correction notices (SCAR).
• Providing CAPA (Corrective Action, Preventative Action) process expertise for projects. Failure Analysis / Root cause investigation, solution development, implementation, and effectiveness monitoring of CAPA files
• Facilitating smooth running of CAPA deadlines by performing IQ, OQ and PQ for Laminators used in production chemistry.
• Performed non product software (NPS) validations, and reviewing validation packages for COTS software Return Goods Authorization (RGA), Finance Spreadsheets, Mat Lab.
• Drafting User Requirement and Functional Requirement Specifications (URS&FRS) based on system owner and customer needs.
• Writing and executing test scripts and performing IQ, OQ and PQ’s for validation of Share Point and Finance Spreadsheets.
• Writing and reviewing Intended Use (IU), Risk Assessment (RA), Trace Matrix, Software Configuration Specifications (SCS), and Software Design Specifications (SDS) as part of CS Validation Life Cycle per TCVS SOP’s.
• Updating and routing CAF’s (Change Analysis Forms) based on changes in validation documents.
• Writing Validation Summary Reports (VSR) and Performing periodic reviews as per guidelines in SOP.

Quality Engineer

Confidential

Responsibilities:

• Responsible for writing protocols, reports forIQ/OQ/PQ of injection molded parts.
• Performing OQ activities such as process determination, shrinkage study.
• Writing First Article Inspection Reports (FAIR’s) and inspecting parts.
• Review Process Qualifications, Process Capability studies (Cp, Cpk, Pp, and Ppk).
• Writing Validation Summary Reports (VSR) based on validation activities and addressing deviations occurred during validations.
• Performed Gage R&R studies and validated various Test Fixtures, Test Assemblies, and Gauges.
• Routing and Drafting Change Requests (CR) in BSC’s software modules like PDM and Wind chill.
• Performed Test Method Validations (TMVs) included both destructive by using Chatillon, Instron and non-destructive testing such as visual inspections using Leica, Smart scope.
• Performing Incoming Inspections for transfer new parts from another production facility.
• Coordinating with transfer plant and requesting new raw samples and sorting and visually verify them for test method validations and process characterizations.
• Involved in the development of cycles for new processes or equipment, which includes development of validation protocols, performing testing, and writing validation reports for manufacturing and Quality Control inspection equipment used to produce PFR male and female urology meshes.
• Assisted on the development and implementation of CAPA plans and test method validation protocols.
• Conducted gap assessment for validation reports and protocols (IQ/OQ/PQ) to assure best validation practices were performed in accordance to BSC’s validation guidelines.
• Ensured products quality by validating hardware, reviewingdesignsto specifications, standards, testability, compatibility, and completeness of documentation.

Quality Engineer

Confidential

Responsibilities:

• Worked on projectCAPAinvestigation and resolution teams, overall risk analysis and in process PFMEA (Process Failure Mode and Effects Analysis).
• Supported quality design assurance activities for Class III medical devices by remediating the Design History File (DHF) that includes Customer Requirements, Product Requirements, System Level Requirements, Hazard Analysis, Design FMEA and Process FMEA.
• Reviewed NCMRs with MRB and manage Corrective/Preventive Actions (CAPAs).
• Execute ProcessandTestMethodValidations(IQ, OQ, PQ, PPQ) in accordance with Customers’ andLake RegionMedical procedures and guidelines
• Developed and implemented risk management (FMEA), quality procedures and policies.
• Provided input todesignand Manufacturing documentation; including material specifications, drawings,inspection procedures, and Manufacturing procedures.
• Developed and implemented Corrective and Preventive Action plans to Nonconforming product.
• Worked within cross-functional group to identify Design/Process deficiencies as found by FDA.