Quality

Quality Documentation Coordinator 3

Address: Mike Allen 1331 Parque Industrial Reynosa, Reynosa, Tamps. 88780, Mexico

Job ID: R0196038

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As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.

A female nurse examining her patient

Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.

A female nurse examining her patient

Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.

A female nurse examining her patient

Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.

A female nurse examining her patient

Job Description

Responsibilities:

  • Perform Checker task in CCNs.
    • To process Change Control Notifications in Windchill and GPDM systems.
  • Review and route Change Control Activities (CCAs).
  • Release changes in Windchill (CCN/DMC).
  • Writes and implements CCNs/DMCs in Windchill system per procedure. Obtains proper approvals to change documents.
  • Responsible for creating a placeholder for new documents on Windchill system or in GPDM.
  • Tracks and distributes Change Control Notices (CCNs) to maintain trail of new and revised documents
    • to ensure compliance with regulations and SOPs.
  • Perform Administrative Changes to correct errors or typos as indicated in procedure.
  • Maintain the integrity of working documents and update documentation when revised.
    • When necessary, will perform revision to the documents in the system.
    • Assembles technical documents according to established procedures and guidelines.
    • Implements and maintains standard operating procedures.
    • Makes recommendations for improvements as necessary.
  • Processes and performs approved changes to affected documents (including drawings, bill of materials, specifications, and product labeling).
  • Update training in Compliance Wire.
    • Upload and perform revision changes to documents in Compliance Wire system in accordance with performed changes through Windchill and GPDM systems.
  • Responsible for controlling and updating approved organizational charts in SharePoint and in the local network folder.
  • To assign Document number of procedures, validations, rework protocols, modules, visual aids, quality alerts, molding, and extrusion control numbers, etc.
    • Update electronics logs.
    • To maintain documentation databases updated.
  • Review quality records. Update/Make corrections to Quality Records when required.
  • This position may be required to support and respond to internal audit observations and corrective actions. Timely and proper response to these requirements will be tied directly to annual performance reviews.
  • Maintains current knowledge of ISO 13485 (most current version) and GMP standards/requirements for medical devices to ensure compliance.

 

Qualifications:

  • Bachelor’s degree.
  • Bilingual English / Spanish.
  • 1 – 2 years’ related experience.
  • Good computer skills and software packages knowledge: SharePoint, Windchill System,
  • GPDM, MS Office, MS VISIO, AutoCAD and SolidWorks.
  • Good data entry skills. Databases (desirable).
  • Bilingual (English-Spanish).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status.

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President

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We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.

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