Quality Manager Qc Inspector

Angelaa Michelson

****************@*****.*** 603-***-**** Shirley, MA

SUMMARY

Dedicated Professional seeking full time remote or part time in person employment in Quality Assurance to leverage immense and varied experience, skills, and knowledge in the field. SKILLS

• QA six sigma yellow belt • Multiple Measuring Program/Tool Experience

• Strong Knowledge of FDA Regulations • DHR Record Keeping

• ISO-13485 Regulations / cGMP Practices • Raw Material, Document Control

• Microsoft Office / Computer Proficient • In-process / DHR’s

• Various Quality Data Program Experience • First Articles, Final and Labels EXPERIENCE

Quality Assurance specialist and Compliance - L3 Essco Ayer, MA Dec 2019 - June 2020

• Compiled procedures, drawings and part specifications with the correct revision for final reviewing for customer

• Reviewed blueprints and ensured correct up to date information

• Verified the correct revisions of blueprints are available and are submitted for customer approval

• Created work instructions and documenting the procedures performed

• Helped train to the correct ISO standards and ensure all data was available and filed prior to moving to next steps

• Ensured there is no missing information from the manufacturing and the inspection of the products

• Performed final inspection including visual and dimensional and finalization of paperwork

• Created charts and analyzed data ensuring approved procedures and expectations were followed

• Notified and created corrective actions and RMRS

• Used multiple tools for measurements, and performed inspection of parts during assembly and final product stage Quality Assurance/Compliance Specialist Manager - F&M plastic Leominster, MA Nov 2017 to Sept 2018

• Managed the quality department delegating tasks and ensuring procedures were followed.

• Created all procedures that needed to be followed to ensure quality was uniform and consistent.

• Made sure all employees were trained on using the proper PPE

• Trained all employees who worked with the product on the quality standards and procedures.

• Created and regulated the training manuals as well as constructed quality books for all departments.

• Created, altered and delegated the work orders on the floor and set up and monitor vision system checks

• Updated the system for the layout for each separate product that was made.

• Ensured supervisors and/or technicians were actively fixing/repairing any issues that arose with the product.

• Help reorganize the process of the product to make a better and more efficient flow.

• Check and monitor the inventory needed for the upcoming batches making sure product was available or ordered.

• Ensured correct labels, boxes, and layout were being used during packing.

• Worked with IT to create programs for quality checks, scrap, a program to automatically create work orders. Quality Control Technician - Fiber optic components, Sterling, MA May 2017 to Nov 2017

• Perform Incoming, Final and In-process inspections

• Used testing tools: Drop indicators, Torque testers, Light meters, Pull testers, frequency meters, indicators micrometers, gages and calipers.

• Used the comparator and the vision system manually as well as during training on these tools and validation of the system with setting up the use of the automatic system which is still in the validation process.

• Read, used, and explained the blueprints to assist engineers fix any mistakes, and perform the inspection reports and for the GD&T to ensure the parts are ready for use.

• Performed corrective action verifying paperwork, making and validating the certificates of compliance, completing the preventative action reports and helping with the MRBS. QA Technician - Nypro medical Devens, MA May 2016 to May 2017

• Responsible for inspecting products at various stages of the production process to maintain quality and reliability of products in accordance with quality plans. Work with Quality Manager, Supervisor, Technicians and other Inspectors and manufacturing personnel to maintain quality conformance on all parts.

• Used various measuring devices to ensure compliance with specifications

• Performed visual, dimensional, mechanical, precision mechanical, functional, or electrical inspection of parts, assemblies or final product in all stages of the production process (incoming, in-process and final inspection).

• Performed inspection tasks involving the use of a wide variety of test instruments, precision measuring devices and electronic equipment to ensure compliance of parts and product with established specifications.

• Dimensionally inspected product for conformance to specification using standard measuring devices such as micrometers, scales, fixtures, calipers, dial indicators, comparators, oscilloscopes, fixed gauges, multi meters, component testers. various surface plate set-ups, plastometers, and thermogravimetric analyzer.

• Performed bar code transactions using Nypro’s Worldwide Bar Code System.

• Maintained/released files for batch history records and/or device history records for completeness and accuracy.

• Identifies workmanship and material defects and maintained required documentation and records.

• Determined acceptability and recommended disposition of defective items in accordance with procedures.

• Worked from written and verbal instructions, procedures, blueprints, diagrams, or statistical processes.

• Selected products for inspection at specified stages in production process and performed visual inspection for variety of defects such as splay, contamination, gross flash, non-fills, short shots, color variation, and grease/oil.

• Initiates nonconforming material reports (NCMR's).

• Metrology requests such as process capability studies, first article inspections, and other special inspections.

• Conducts, documents, and reports on process audits of assembly/molding processes.

• Supports all company safety and quality programs and initiatives.

• Input Statistical Process Control data in Predisys/created DCF including collection of inspection data and charts. QC/QA Inspector - Micron (contract) Fitchburg, MA Oct 2014 to Feb 2015

• Used Standard dimensional gages, caliper, micrometer, drop indicator, comparator, height gage, force gage.

• Performed documentation review, and dimensional verification of materials for errors before signing off.

• Verified product visually and dimensionally through in-process and final inspections.

• Audited processes for compliance with established policies / procedures.

• Evaluated non-confirming material to provide input regarding condition.

• Performed First Article Inspections under the direction of Quality / Engineering and updates Quality System logs.

• Completed quality records accurately and legibly; filed appropriately.

• Complied with area safety requirements, as well as ISO 9001, ISO 13485 Quality Systems, and GMP practices

• Worked with manufacturing engineers and managers to ensure procedures were followed, and/or issues resolved

• Visually inspected parts for defects and made sure things were fixed in a timely manner

• Trained new inspectors and updated other inspectors of changes made to the process

• Maintained a relationship with managers, engineers and other employees involved to ensure a smooth process. QA/QC Inspector (contract) - Teleflex Medical Chelmsford MA Feb 2014 to June 2014

• Performed inspections of incoming parts using the manufacturing process cGMP practices/ISO-13485 regulations

• Created, altered and checked blueprints to the requests of the customer of the incoming product

• Answered and worked with engineers when there was a question with the data found later in the process

• Maintained DHR/created forms ensuring products were received with correct amounts and appropriate paperwork

• Contacted suppliers when all applicable paperwork was not present or when measurements were not signed off

• Received all products into the system, and used multiple measuring tools such as calipers and gages

• Collected data on the flow of the receiving process to create standardized processes

• Located issues with the process and helped improve and minimize the errors

• Assisted Quality Manager learn the process of incoming parts, computer system and how to create documents QA Technician (contract) - Timken Quality Keene, NH April 2013 to Sept 2013

• Performed visual inspection of in-process material and final inspection practicing cGMP practices/ISO regulations.

• Interfaced with engineers detailing results from findings on complex parts, first article pieces and NCR lots.

• Inspected first article pieces to ensure their performance met specifications and ran per customer requirements.

• Used machines to perform inspections of the roundness, radius and axis of products insuring they met standards.

• Conducted dirt count (environmental procedure) on some final and in-process products to ensure cleanliness.

• Set up, read traces, calibrated torque machine and maintained DHR records throughout the process.

• Used a variety of gages and measuring devices to perform performance clearance and inspection.

• Used calibration processes to ensure the machines were accurate and up to date.

• Worked in multiple departments as a result of possessing multiple skill sets.

• Learned processed quickly to become useful on various steps throughout the process.

• Worked on such steps as sand blasting, heat treat, crimping, laser, assembly to name a few. Quality Control Inspector (contract) - St. Jude Medical, Inc. Westford, MA May 2012 to March 2013

• Performed inspections throughout the manufacturing process (cGMP practices and ISO-13485 regulations) used for the assembly of fiber optic constructed cardiovascular video catheters.

• Performed visual, dimensional and functional inspection according to documented policies and procedures.

• Gathered and analyzed trending of data to develop and recommend changes to inspection procedures

• Documented nonconformance and maintained DHR records and supported validation/qualification processes.

• Recorded inspection and test data as prescribed by written instructions and procedures.

• Operated all associated test and measurement equipment as instructed in procedures.

• Developed and recommended changes to inspection procedures.

• Recommended changes to policies, procedures and inspection requirements to assist in improving the process.

• Performed testing and inspection in accordance with special test requests.

• Contributed to test and measurement equipment selection.

• Interfaced with suppliers as required in support of material quality / technical inspections.

• Trained inspection staff on use of equipment.

• Informed operators of defaults and problems that arise

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