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Staff Quality

Des Moines, Iowa, United States
May 25, 2018

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David Coates

Chemist, Biologist, Regulatory Affairs, Customer Focus Specialist and Teacher

West Des Moines, IA


Willing to relocate to: Des Moines, IA

Authorized to work in the US for any employer

Work Experience

Bentley Contractor

Medtronic - Mounds View, MN

June 2017 to Present

Customer Focused Quality Specialist: 24 Month Contract

• Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.

• Define recall strategy and actions that are compliant with all applicable regulations and internal procedures to properly address a product quality issue.

• Facilitate the development of FCA materials (letters, presentations, etc ) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and Medtronic field personnel to mitigate patient risks.

• Identify FCA strategies, actions and milestones to be included in the FCA plan.

• Negotiate resolution of issues impacting FCA planning.

• Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.

• Oversee the global execution of the global FCA plan to ensure adherence to plan actions and milestones.

• Analyze current business processes and identify best practices to develop improved, standardized processes for Product Hold Orders (PHO) and FCAs.

• Coordinate with different stakeholders in supply chain and quality to initiate, execute, reconcile and close Product Hold Orders

• Assist in the response to regulatory inquiries related to Field Corrective Actions • Ensure that the FCA plan follows all applicable internal, corporate and regulatory standards or requirements.

• Provide support for internal and external inspections. May present information directly to internal or external auditors.

• Maintain data and prepare reports, presentations, proposals and status updates for management. Volt Contractor

St. Jude Medical Inc - Plymouth, MN

December 2016 to June 2017

External Analyst II - Post Surveillance Service Division: 6 Month Contract

• Update and complete FDA Reports for prophylactically removed medical devices.

• Update and complete Warranty Reports for prophylactically removed medical devices.

• Electronically process events to determine complaint and report ability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.

• Ensure complaint investigations are adequate, accurate, detailed and timely.

• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.

• Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.

• Complete electronic submission of MDRs to the FDA.

• Ensure accurate data entry, scanning, and retention of documents to complete event files.

• Proficient with internal systems, methods, and procedures to maintain compliance and support post- market surveillance. Evaluate and recommend changes to current systems.

• Develop and demonstrate proficient knowledge of CRHF products.

• Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.

• Maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.

• Identify and complete projects to advance post-market quality and complaint handling.

• Support review and modification of department procedures as necessary to stay current with corporate standards and regulations.

• Support continuous improvement and internal audits of peer work to reduce errors and increase compliance.

Education Staff Member

Merlin Entertainment - SEA LIFE Aquarium - Bloomington, MN June 2016 to December 2016

P-T Employee: Bloomington, MN June 2016 - Dec 2016 Education and Operations Employee - SEA LIFE Aquarium, MOA

• Education Staff Member

Behind the Scenes Tour Guide

Member of the Green Team

Snorkel Host

Educational Tour Guide

Ocean Conservation Teaching Staff

K - 6

6 - 8

8 - 12

• Duties Include:

Help in developing, delivering and evaluating the educational programs and presentation scripts at the site to support the SEA LIFE brand.

Ensure that the programs follow local educational standards and best practices in an informal science education setting. All programs must meet the needs of all of our guests: guests of any age, guests with special needs as well as students and teachers. Programs need to have a strong focus in line with SEA LIFE's "Breed-Rescue-Protect" program.

Helped in developing training materials for guest facing positions, and updates the materials regularly.

Liaises with Education Specialists at other US SEA LIFE Aquariums to maintain consistency and quality of the educational programs.

Working with the marketing and operations staff develops annual and three-year goals for program reach (number of programs, number of participants), educational impact, KPI impacts, and revenue.

Responsible for organization and use of the site's education classroom, along with any extra storage area for educational materials.

Participates in the planning of new developments and exhibits at the site, to ensure that they are fun and engaging, and have appropriate and relevant educational content and information delivery systems.

As needed, reviews the regional and site-specific digital and printed marketing and communication materials for accuracy. Updates and maintains the species ID panels, in collaboration with the Displays Curator.

Help maintain an inventory for all program props, education materials and supplies, maintains on-site SEA LIFE Library while liaising with the Displays Curator.

Working with the Displays Curator, develops the educational goals as well as assists with the supervision of the guest interactions at the touch pool and within any other "animal ambassador" and/or dive programs. Ensures that all SEA LIFE/MAWD policies and procedures are followed with the highest level of animal wellness.

Participates in local and - where possible - national education-related conferences and meetings, to build SEA LIFE's credibility, develop personal education-related networks, and stay abreast of current informal science education thinking and methodologies.

Participates in and supports the site's Green Team, and takes a lead role in the site's local conservation efforts.

Supports the site's involvement with the programs and campaigns of the SEA LIFE Trust.

Develops and maintains excellent relations with local schools, including the home school community, and (where relevant) local colleges and universities.

Other duties as assigned.

• Operation Staff Member

Rock Pool Staff Member

Ray Pool Staff Member

Check Point Staff Member

Photo Entrance Staff Member



Ray Photo Staff Member

Closer/Safety Security Member

• Duties Include:

Adopts an enthusiastic, assertive and passionate approach to Guest Service, and demonstrates the Merlin Values at every opportunity.

Works in a team rotation with touch pools and various other positions throughout the aquarium.

Inspires children by playing with props and demonstrating possibilities of the materials, while maintaining an open-ended approach.

Floats within area and directly communicates with guests by greeting, explaining, demonstrating. Is alert to guests need for assistance and independence.

Maintains excellent knowledge of all program content, and is thoroughly familiar with aquarium displays and species, in order to reference and recommend extended learning.

Facilitates public talks using public announce systems and microphones.

Informally surveys teacher and child satisfaction with program, communicates suggestions. Gives input regarding programs' strength and weakness. Encourages school guests to complete satisfaction surveys.

Ensure that our extended queue lines are managed in a safe way while still delivering an excellent guest experience.

Ensures aquariums are clean, organized and ready to open on a daily basis. Assist in clearing the building for closing.

Maintains overall cleanliness and beautification of SEA LIFE, including, but not limited to, sweeping, stocking the restrooms, and helping pick up trash. Regulatory Assistant - Cortec Corporation Regulatory Division Cortec Corporation - Aerotek - Saint Paul, MN

September 2015 to June 2016

Saint Paul, Minnesota September 2015 - June 2016

Regulatory Assistant - Cortec Corporation Regulatory Division

• Author Safety Data Sheets (SDS)

• Review labels for compliance with local, national, and international labeling requirements

• Contribute to process improvement in the areas of label authoring, buyout products/acquisitions, etc.

• Respond to internal and external inquiries regarding transportation classifications, consumer questions, etc.

• Provide regulatory guidance during product development

• Communicate with marketing staff to answer regulatory questions and provide guidance

• Communicate with trade associations and government agencies

• Develop cross functional teams to improve processes like formula change management, product label development, and TSCA import/export tracking and reporting - identify problems and take action to correct issues

• Provide regulatory guidance to marketing, sales, transportation, and purchasing staff Raw Material / Vendor Management Coordinator

3M - Health Care Business Group - Saint Paul, MN

March 2014 to September 2015

- Infection Prevention Division, FSD, CHC and C3SD

• Drives the division raw material process.

• Monitors and administers RM policies and procedures.

• Administers approval process for RM Specifications internally and from suppliers for ne revised RM's Communicates RM information and requirements plant locations, writes, revises and reviews RM Specifications in accordance with corporate guidelines.

• Actively participates in Division Supplier Management Program.

• Participates in and/or leads Division Supplier Relations Meetings.

• Functions as control point for supplier performance reporting.

• Responsible for supplier surveys and coordinates supplier certification process.

• Responsible for maintaining documentation regarding ISO Certification ISO Certification and FDA QSR Compliance.

• Administers and coordinates supplier notification of changes with purchasing, manufacturing and laboratory.

• Coordinates supplier corrective action process.

• Assist in identification and qualification of new RM suppliers.

• Responsible for assisting in development of Division yearly forecast for RM requirements.

• Coordinates other RM and /or supplier-related documentation as required. Performs other duties as assigned.


3M - Corporate Research Laboratory - Saint Paul, MN August 2008 to March 2014

Product Responsibility Liaison - S.E.M.S. Division -

• Actively contribute to product development efforts by assuming responsibility for regulatory compliance and life cycle management. The activities include generating MSDS's and labels, RM specifications, conducting chemical inventory reviews, and utilizing the life cycle management tools with input from staff functions to ensure timely release of new, reformulated and outsourced products.

• Responsible for hard goods safety evaluations, EHS corporate metrics reporting and transportation classification.

• Responsible for gathering regulatory data on products in the 3M Divisions to include: updating, writing MSDS, updating and writing specification on raw materials. Instructor of Physical Science


July 2007 to November 2007

Responsible for instructing high school students in two areas of science: Physical Science and Environmental Science.

Instructor of Physics, Physical Science and Chemistry TURNER COUNTY HIGH SCHOOL - Ashburn, GA

February 2007 to May 2007

Responsible for instructing high school students in three areas of science: Physics, Physical Science, and Chemistry.

Instructor of Biology and Chemistry


March 2000 to December 2005

• Responsible for all aspects of instructing middle and high school students in Chemistry, Physical Science, General Math, and Biology on a private military preparatory campus.

• Additional volunteer duties included Golf coach, weekend trip chaperone, Class C Bus Driver, Stream Sweep Sponsor, and Science Olympiad Sponsor.

Owner and Operator


October 1997 to December 1999

Responsible for all aspects of daily operations of an independent small business specialized in residential home inspections.

Chemist/ Chemical Hygiene Officer, Quality Assurance Division FAST FOOD MERCHANDISERS INC - Monterey, TN

August 1994 to October 1997

Supervised Q.A. personnel and all aspects of on shift quality operations including monitoring waste water, sourcing and implementing equipment upgrades, conducting daily pre-operational and annual inspections, directing laboratory safety meeting and training, writing SOPs for Lab and maintaining MSDS files.

Receiving Chemist, Quality Assurance Division


May 1994 to July 1994

Responsible for testing incoming raw materials both inactive and active ingredients, using Merck S.T.P., conducting test operating NIR, GC, HPLC as well as maintaining and calibrating equipment, tracking quality according to the guidelines for GMP and sanitation. Laboratory Technician, Clinton Nuclear Power Station ILLINOIS POWER COMPANY - Decatur, IL

July 1990 to May 1994

• Responsible for environmental monitoring program including ground water sampling and testing related to UST/LUST, Lake environment testing, soil testing for PCB's, Coal analysis and biological monitoring.

• Specific duties included maintenance and use of GC, AA, BTEX, IC, TOC as well as knowledge of chain-of-custody, HAZMAT, OSHA/EPA regulation for collection and disposal of hazardous waste and results reporting.



University of Georgia


Master of Science in Environmental Biology

Eastern Illinois University

May 1990

Bachelor of Science in Zoology

Eastern Illinois University

December 1987

Additional Information

Work Awards:

Merlin Entertainment Award -STAR – 02/06/17 – Thank You -We Care Unknown, Could not find out. (Left in Dec 2016)

Merlin Entertainment Award -STAR – 12/05/16 – We Care Dave, not only are you a pleasure to work with, you are a fantastic tour guide. You are attentive to guest and always keep them interested and laughing! Thank you so much for making our jobs easier and more fun.

Erica Colon

Merlin Entertainment Award - STAR – 08/24/16 – We Love What We Do A guest did not want to take the survey but wanted David to know what a GREAT job he did! Jessica Mitrani, HR Director

Merlin Entertainment Award - STAR – 08/08/16 – Thank you – We Care For going out of your way to be helpful and making the back offices sparkle and shine. Ariane Heideman, Duty Manager

TF/TC Instant Recognition Award, 6/29/15 by Greg Yeager, 3M Critical and Chronic Care Solutions Division Thank you for completing 22 raw materials for the Ivera integration project and for continuing to communicate with me on the status as RMS set up progressed. I look forward to your continued prompt customer service to advance the Vascular Access Business. TF/TC Instant Recognition Award, 6/13/14 by Linda L. Brown. 3M Critical and Chronic Care Solutions Division David, Your help and kindness to collaboration with 3M Corporate to understanding the issue and navigate the RM eMatrix/SAP system glitches to update and release the NYLON RM Specs was very much appreciated. You got it done and I could not have done it without you! Thank you! Linda L. Brown

Volt “Wow” Award: 02/07/14 by Ann Parenteau For work above and beyond the call of duty in reactivating some raw material transportation codes on extremely short notice -- thereby allowing a sample shipment to proceed and a coating run to occur. TF/TC Instant Recognition Award, 1/29/2014 by Mark J. Pellerite. For work above and beyond the call of duty in reactivating some raw material transportation codes on extremely short notice -- thereby allowing a sample shipment to proceed and a coating run to occur. Thanks much, Dave! Volt “Wow” Award: 01/17/14 by Ann Parenteau Outstanding Support for the Fuel Cell Components chemical audit. Dave worked with a team to inventory the materials used in the Fuel Cell Labs. Some 600 substances were catalogued. The labs are working labs, with large number compounds, the work highly repetitious. The support was given cheerfully and it made the process much more manageable! THANK YOU!

TF/TC Instant Recognition Award, 1/14/2014 by Randall P. Brown. For outstanding support, the Fuel Cell Components chemical audit. Peter, David and Rob inventoried the materials used in the Fuel Cell Labs. Some 600 substances were catalogued. The labs are working Labs, and with large number of compounds, the work highly repetitious. The support was given cheerfully, and it made the process much more manageable! Thanks!

Volt “Wow” Award: 01/09/14 by Ann Parenteau, In recognition of outstanding accomplishments and contributions. David was able to help assist the Mining, Oil, and Gas System (MOGS) Group ship air monitors to 3M Chile. David was a big help having the packages ready for safe shipping. Volt “Wow” Award: 12/19/13 by Ann Parenteau David effectively help CRML and our 3M PI partner, by working internally to generate an MSDS form at record speed, for the Shipping of a high priority material, your very timely work is greatly appreciated! TF/TC Instant Recognition Award, 12/4/13 by Meredith McMurdo Doyle. David effectively help CRML and our 3M PI partner, by working internally to generate an MSDS form at record speed, for the Shipping of a high priority material, Your very timely work is greatly appreciated! Volt “Wow” Award: 8/5/2013: In recognition of outstanding accomplishment and contributions, David has been acknowledged for his fantastic help he provides on obtaining all the transportation codes and assistance in shipping materials off the 3M campus. There has not been one missed coating or delay coating experiment due to the efficient help David provided with resolving these matters. One of David’s supervisors had a problem with transportation not being able to ship one of the materials. It was a material that has been shipped before and never had a problem. David got to work on the problem and had new codes set up for this material and resolved the issue by the time he left for the day. Transportation was able to ship the chemical out and will arrive in plenty of time for the experiment. David is always able to give professional and timely help. TF/TC Instant Recognition Award 2/8/13 David has done an outstanding job of creating new MSDS(s) and getting the Environmental and Tox Reviews done in time for three new formulations that were urgently needed to be shipped to 3M India and 3M Germany. GREAT JOB Thank you again!

Nominations for the 2012 Circle of Technical Excellence and Innovation (CTE&I) award program: Work with the RoHS II Team at 3M

TF/TC Instant Recognition Awards 6/06/12 and 6/21/12 Work Awards Volt “Wow” Award: 4/26/12 you did a very timely and excellent job generating a new MSDS and Transportation Classification for some material made at 3M Eagan and needed to process further up at 3M Center. Your efforts allowed us to ship the material faster and keep the project moving. Gem Award: (2009) For Going the extra mile, for a fantastic job in getting our raw material specification update this year (2009)

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