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Manager, Customer Feedback – Argon Medical – Athens, TX

Summary Description of this Job: Directs the planning, preparation and facilitates the timely submissions of all MDR, Vigilance and other regulatory reports to the appropriate regulatory authorities globally. Guides regulatory reporting activities globally, provides clinical expertise for PMS related activities. Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction. This position will hire staff, and conduct performance reviews and fulfill other management responsibilities. Successful candidate will have proven organizational skills with track record of achieving positive results.

Essential Duties and Responsibilities:

  • Communicates with customers to establish a full understanding of alleged adverse events.
  • Analyzes medical device reporting data to identify trends. Notifies designated internal personnel with appropriate findings and
    recommendations. Enables rapid and effective escalation and investigation of potential safety related issues.
  • Responsible for leading the Product Experience analysts’ team, manages workflow and processes. Supports the Product Experience Group in leading and directing the global process activities
  • Trains direct reports to ensure proper implementation and use of quality tools and procedures as required.
  • Manages complaint workflow and the processing of complaints within software applications
  • Interacts with Regulatory Authorities to answer follow-up questions, provide investigation details
  • Provides guidance on clinical risks and outcomes associated with medical device malfunctions
  • Assist or lead general compliance activities as required.
  • Other duties as assigned

Requirements:

Education/Degree:
Bachelor’s Degree in science, math or engineering discipline.   General knowledge of basic physiology, high level of research, analytical and problem solving skills; ability to prioritize for maximum results (multitask management)

Qualifications:

Excellent communication skills, ability to manage multiple priorities, creative problem-solving ability; excellent oral and written presentation skills; team oriented; good planning and organizational skills. General knowledge of basic human physiology.

Demonstrated interpersonal skills to successfully partner with individuals to build relationships with business contacts, customers and regulatory entities.  Demonstrated capability to direct employees working with cross-functional teams to resolve customer issues *

Capability to train reports on QSR, Medical Device Directive, and ISO Quality System Standards. EU MDR understanding is a plus. Proven excellent analytical, decision making, and problem-solving skills to successfully define problems, collect data, establish facts and draw accurate conclusions, and to train and manage direct reports to do the same.

Licensing/Certificates:
CQA or CBA or RABSQA required. CQE and CQMgr/OE certifications preferred.

Computer Skills:

Minitab software or similar statistical analysis software tool; General Microsoft Office applications. Work experience with electronic QMS software.

Experience:

Minimum 7 – 10 years of work experience in regulated healthcare environment (ISO 13485:2016 and 21 CFR 820); past participation in Notified Body and FDA audits. Strong knowledge of applicable standards and guidance documents; ability to lead and mentor in a team environment.

If interested in this position, please send copy of your resume and contact information to Kelsey George at the following address: Kelsey.George@argonmedical.com.

Professional Development Meeting – 2019 March

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Come join us for the first in a three part series focusing on Quality 4.0 The future of Quality. As we prepare to co-host the 2019 ASQ World Conference on Quality and Improvement in Fort Worth in May, let’s discover the future of Quality.

Presentation:

Multi Team Systems

Dr. Baker and Dr. Turner will discuss a scientific paper they co-authored regarding Multi Team Systems along with Toyota Connected of Toyota Motor Corporation. This has now been published in a scientific peered reviewed journal, The Journal Of Technology Management. They will discuss utilizing Multi Team Systems to improve Agility in Lean Product Development at Scale.  Its a subject that they have presented on internationally. This will extend our conversation of Scrum and related work processes that we started at the February Professional Development meeting.

Speakers:

Dr. Rose Baker and Dr. John Turner are assistant professors in the College of Information, Department of Learning Technologies at the University of North Texas in Denton.  Their research interests are in adult education,work place learning and performance, teams, team cognition, knowledge management, performance improvement, leadership, theory building, multilevel models, and meta-analysis techniques. Publications include articles in Advances in Developing Human Resources, Performance Improvement Quarterly, Performance Improvement, Journal of Knowledge Management, and International Journal of Technology, Knowledge, & Society.


Meeting Information

Meeting Date: 28th March 2019
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

Meeting Location:
Ten50 BBQ
1050 N Central Expy, Richardson, TX 75080

Register Now !

Professional Development Meeting – 2019 February 28th

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Come join us for the first in a three part series focusing on Quality 4.0 The future of Quality. As we prepare to co-host the 2019 ASQ World Conference on Quality and Improvement in Fort Worth in May, let’s discover the future of Quality.

Presentation:

Scrum 101

Let’s learn about Software Quality through a basic introduction to the Agile Scrum process: Scrum 101. Linda Westfall of The Westfall Team will describe the duties of the three major Scrum roles of Product Owner, Scrum Development Team and Scrum Master. It will also discuss the basic steps in the Scrum process including the:

  • Scrum Planning Meeting
  • Sprint (Iteration) and Scrum Meeting (Daily Stand-Up)
  • Sprint Demonstration
  • Sprint Retrospective
  • Product Backlog Refinement Meeting

Speaker:

Linda Westfall is the President of The Westfall Team and one of their lead consultants/trainers. Her specialties include Software Quality Engineering, Metrics, Project & Risk Management, Requirements Engineering & Management, Peer Reviews, Testing, and Process Definition & Improvement.

Prior to starting her own business, Linda was the Senior Manager of Quality Metrics and Analysis at DSC Communications. Linda has more than forty years of experience in real time software engineering, quality, project and risk management, agile and metrics. She has worked as a Software Engineer, Systems Analyst, Software Process Engineer and Manager of Production Software.

Very active professionally, Linda Westfall is an ASQ Fellow and a past Chair of the American Society for Quality (ASQ) Software Division. She has also served as the Software Division’s Program Chair, Certification Chair and Newsletter Chair, and on the ASQ National Certification Board. Linda was a significant contributor to the 3rd and 4th Editions of the Project Management Institute’s (PMI) Project Management Body of Knowledge (PMBOK®) Guide and worked on the exam development committee for the Professional Engineer (PE) license for Software Engineering. Linda is a:

  • Professional Engineer (PE) in Software Engineering in the state of Texas.
  • ASQ Certified Software Quality Engineer (CSQE), Certified Manager or Quality Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA).
  • Certified Project Management Professional (PMP) from the Project Management Institute (PMI)
  • Certified Scrum Master and Certified Product Owner from the Scrum Alliance
  • Certified SAFe Program Consultant (SPC), SAFe Agilist (SA), SAFe Product Owner/Product Manager (SPO/PM) and SAFe Advanced Scrum Master from Scaled Agile, Inc.
  • Lean Six Sigma Master Black Belt from Villanova University
  • Certified Tester from the International Software Testing Qualification Board (ISTQB)

She has her MBA from the University of Texas at Dallas and BS in Mathematics from Carnegie-Mellon University.
Linda is the author of The Certified Software Quality Engineer Handbook, 2nd Edition published by ASQ Quality Press.
Linda can be contacted at lwestfall@westfallteam.com.


Meeting Information

Meeting Date: 28th February 2019
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

Meeting Location:
Ten50 BBQ
1050 N Central Expy, Richardson, TX 75080

Register Now !

 

Update!

Presentation Slides: Scrum 101 – Linda Westfall

Professional Development Meeting – 2019 January 24th

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Tutorial:

“myASQ”

A centralized online community providing timely, relevant and customizable engagement for ASQ members and quality professionals around the globe.

Speaker:

Russell Wood, Chair Section 1402 Dallas, TX

 


Presentation:

ISO 19011:2018 – Revised Guidelines for Auditing Management Systems

Find out the changes from the prior version of the standard, and learn how to manage an audit system in any type of company.  This is a master class in audit system understanding by a highly experienced audit and process professional.  Don’t miss it.

Speaker:

John Jennings, CSSBB, CQE, CRE, CQA, CSQE. John is the Quality Assurance Manager for Bowhead Manufacturing. He brings experience as an audit and process professional within an organization in addition to his Baldridge examiner experience to provide valuable insights.


Meeting Information

Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

Meeting Location:
Ten50 BBQ
1050 N Central Expy, Richardson, TX 75080

Register Now !


Update!

Tutorial Slides: myASQ

Presentation Slides: Changes to ISO19011 – “Guidelines for Auditing Management Systems”

2019 World Conference – Volunteers Wanted

The ASQ World Conference on Quality and Improvement (WCQI) is coming to Ft Worth next year. After years of seeking it, we got a surprise in Dec 2017 with the announcement Fort Worth would be the Host City. WE ARE EXCITED!

We have formed a Core Site Committee of members from both Ft Worth and Dallas Sections. This team attended the Seattle WCQI in May, met in June to discuss our approach, and are now ready to take the names of members who want to volunteer to staff it.

Volunteer Role/s include:

  • 8 total hours of volunteer time (single / multiple days)
  • Monitor Session Presentation Rooms – room administration
  • Information Tables – conference and Ft Worth City opportunities
  • General Help – background support of the attendees / conference

It will be held at the Ft Worth Convention Center and the Omni Hotel, Sat to Wed, May 18-22, 2019. Staffing include weekend jobs. Volunteers get complimentary entry to the 3-Day Conference (a $1000+ value).

To register your interest in being a volunteer, we are accepting member names. This is not yet a firm commitment, as we will not know our actual staffing requirements until Feb 2019. A confirmation of availability will be sent to those signing up now at www.tinyurl.com/WCQI-2019-VOL.

Professional Development Meeting – 2018 November 29th

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Presentation:

TAMU-C Business Management/Quality Partnering Opportunities

Topics:

  • Overview of the TAMU-C College of Business management programs coming in Spring 2019
  • Soft Sills: Leadership, Organizational Behavior, Communication, and Strategic Management components of programs
  • Managerial Tools and Techniques components of programs (Project Management, Supply Chain, Operations and Six Sigma)
  • Pilot Program: Results from strategic partnership with L-3

 

About the Speakers:

Dr. Mario Hayek is an Associate Professor and the head of the management department in the College of Business at Texas A&M Commerce. He obtained an MBA with emphases in Finance and Entrepreneurship from the American University in Washington D.C. and a Ph.D. in management from the University of Mississippi; he has been teaching for over 20 years. As an entrepreneur, Dr. Hayek has launched a number of new ventures in Latin America and the Unites States including a recycling plant, hotel, restaurants, bar, travel agency and commercial real estate. As an academic, his research interests include entrepreneurship, leadership, organizational behavior, social responsibility and ethics.

Dr. Alex Williams is an Associate Professor in the College of Business at Texas A&M Commerce, where he teaches organizational behavior and human resources. His primary research interests include Leadership & Organizational Behavior. He earned his Ph.D. in Management at The University of Mississippi and his BA in Accounting from Morehouse College (Atlanta, GA).  He is a 2017 Hunt/Hopkins County Professor of the year, the 2016 recipient of the Neill Humfeld Distinguished Faculty Award for Service, and the 2015 Faculty Senate Award for Teaching with Technology. Additionally, he has extensive experience as both a business professional and a social entrepreneur.

Dr. Jerry Burch is an Assistant Professor in the College of Business at Texas A&M Commerce and has over 25 years of Supply Chain experience focusing on process improvement and time series forecasting. He received his Masters of Science in Operations Research/Operations Logistics and earned his Master Blackbelt while working with the Defense Logistics Agency. He has also earned his Ph.D. in Management (Organizational Behavior) with minor area of study in Decision Sciences. His research has been published in many top rated journals including the International Journal of Forecasting and Decision Sciences Journal of Innovative Education.

 Tom Brown completes a 35 year career, retiring as Senior Vice President of Human Resources for the Aerospace Systems Segment at L3 Technologies at he end of this year. Tom has extensive HR experience as a specialist in compensation, information systems, management development training, staffing, and benefits as well as in HR generalist roles throughout his career. His previous employers include Raytheon, Alcatel and Bank One. He holds a Master of Business Administration in human resource management from the University of Dallas and a Master of Liberal Arts from Southern Methodist University.  He also serves as Vice Chairman of the Board of Trustees for Lakes Regional Community Centers (MHMR), and is a member of the Autism Society of America.

 


Meeting Information

Meeting Date: November 29, 2018
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

Meeting Location:
Crowne Plaza Addison
14315 Midway Rd, Addison, TX 75001

Register Now !

Update!

Presentation Slides: A&M Commerce College of Business – Overview