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.

ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.

Career change in your future?

Our jobs posting service is back on-line and going strong. The format is a little different but easy to navigate.

If you are looking for a new position, click on the CAREER/Career Opportunities tab at the top of the home page, and check out all the new additions.These jobs are not only local, but throughout the US, looking for skills from food to biotech at many different job levels.

Joe Eudy from the Ft. Worth section is also busy posting resumes to our members who want more publicity.  If you have an opening you might want to read through the resumes of those who are already out there. If you would like your resume posted, just contact Joe through the page link and send him an email.  For faster response, please put “ASQ- RESUME POSTING” in the email posting and he will get to it asap.

Happy Hunting!