Quality Assurance Control

Michael R Burns

**** *********** **. ****** **, *0831 719-***-**** email: *******.*.*****@******.**

PROFILE OF QUALIFICATIONS

Almost 5 years quality assurance experience with Philips in Class 3 medical devices with 3 of those years as a Quality Engineer. The following is an outline of skills acquired that are relevant to this position:

-Material Review Board

-ISO 13485

-FDA 21 CFR part 820

-Quality Control

-Quality Assurance

-Risk Management

-EUMDR compliance

-CMM / OGP

-DMAIC

-Engineering Changes

-Test Method Validation

-Measurement Methods

-Process validation

-ISO 9001

-Audit/Spot check

Background reflects exceptional work ethic, resourcefulness, adaptability, sound judgement and outstanding team player on a variety of diverse teams.

Technology: SolidWorks … Autodesk … Minitab … MATLAB … Oracle … SAP ... Excel … PowerPoint … Word … Outlook ... Power BI ... ARIS

EXPERIENCE HIGHLIGHTS

JAN 2023 – MAY 2023 COLLINS AEROSPACE Colorado Springs, CO

Engineer II, Quality

Liaison between customers and production floor for all material quality issues and improvement processes. Investigated root-cause and for identified issues and worked with cross functional teams including; production personnel, manufacturing engineering and final customer, to implement and monitor corrective actions.

Facilitated collaboration on final product sub-level builds, quality defects, escapes, critical quality metrics, updates to work instructions, customer/supplier correspondence for all product lines.

Led communication/training for production teams on assigned product lines for defects, reworks, test failures, process improvements, etc.

Reviewed and approved over 100 in house First Article Inspections in corrective action for customers.

SEP 2020 – AUG 2022 PHILIPS Bothell, WA

Manufacturing Quality Engineering

Performed product and process nonconformance evaluations and approvals. Provided support for operations and manufacturing activities from a Quality Engineering perspective, to ensure sound methodology and compliance to all applicable standards and regulations. Performed spot checks on various processes and areas within operations. Assisted in CAPAs and findings as appropriate. Lead and participated in daily Material Review Board (MRB). Conducted monthly data analysis and trending of nonconformances for monthly Product Data Monitoring. Created, reviewed, and approved Work Instructions and Standard Operating Procedures to ensure compliance with the Quality Management System (QMS). Reviewed and approved design and process FMEA's. Utilized FMEA's on a daily basis to aid in determination of the level of patient safety risk for nonconforming materials. Proposed updates to FMEA's for risk characteristics .

Over 1700 Quality Notifications evaluated, investigated and/or approved. Utilized fishbone diagrams, 5 why’s, DMAIC, and various other quality tools to assist in determining root cause.

Updated or reviewed and approved more than 100 Work Instructions and Standard Operating Procedures via EC in accordance with local QMS.

AUG 2019 – SEP 2020 PHILIPS Bothell, WA

Quality Inspection Engineer

Created, validated and approved Receiving Inspection Plans. Oversaw daily receiving inspection activities, providing guidance Quality Control Inspectors where required. Trained all Receiving Inspection personnel in; understanding engineering specifications, GD&T, proper use of inspection tools, use of software systems, and too applicable Work Instructions and Sta Assisted with CAPA investigations and coordinated RI support. Conducted and submitted Test Method Validations. Developed and submitted and maintained the RI Master Validation Plan.

Participated in the creation, review and validation of over 100 inspection plans

Validated over 20 different test methods and tools

SEP 2017 – AUG 2019 PHILIPS Colorado Springs, CO

Quality Control Inspector II, Receiving Inspection

Ensure quality standards are in accordance with company SOPs through International standards to include ISO13485 and ISO9001. Conduct first article inspections as well as IQ’s, OQ’s and PQ’s, in order to validate parts for production. Utilize in-depth knowledge of Geometric Dimensioning and Tolerancing (GD&T) in the inspection process. Control non-conforming parts in quarantine and initiate, monitor and close Non-Conformance Reports in cooperation with the Material Review Board. Review dispositions for completeness and correctness before closing NCR’s and releasing inventory to production. Interface with engineering, quality, and production teammates to effectively communicate quality standards and address issues in a timely manner. Participate in internal and external audits.

Over 50 successful programs created on Coordinate Measuring Machines (CMM) reducing inspection time dramatically.

Over 200 First articles, IQ's, OQ’s and PQ’s conducted.

More than 1600 inspections completed.

APR 2006 – NOV 2012 UNITED STATES ARMY Various Cities

Sergeant

Trained maintenance personnel on safe and proper heavy equipment operations, such as wreckers and forklifts, proper use of hand tools and general shop safety. Conducted training for all unit personnel on how to drive tactical vehicles, operate generators, and perform preventive maintenance. Certified over 100 vehicles for international shipment in accordance with all local, state, Army, federal (CFR 49) international regulations. Ensured all safety regulations were followed by personnel in the maintenance facility at all times through education, observation and leadership. Oversaw 100% accuracy of hazardous material inventory in full compliance with laws and regulations at international, federal, Army and state government levels as the environmental compliance officer. Conducted quality control inspections on all vehicles after servicing and before signing vehicles out in order to ensure maintenance personnel performed the job properly and vehicles were safe for use.

Maintained mechanical readiness of over 10 million dollars in equipment ranging from 5-ton tactical trucks all the way down to rifles and lawnmowers. Resulting in a minimum of 97% operational readiness at all times.

Honorable Discharge NOV 2012.

Received the Army Commendation Medal and 4 Army Achievement medals for exceptional service and commitment to the unit and team.

EDUCATION

Bachelor of Science: Mechanical Engineering 2017

UNIVERSITY OF COLORADO, COLORADO SPRINGS Colorado Springs, CO

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