Quality

Quality Engineer 1 - (MX-REY) - Bl Quality Engineer

Address: Mike Allen 1331 Parque Industrial Reynosa, Reynosa, Tamps. 88788, Mexico

Job ID: R0192167

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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:

  • Responsible for supporting the development of corrective/preventive actions (CAPA) corresponding to the assigned manufacturing area.
  • Coordinate/lead root cause investigation tasks with investigation team.
  • Coordinate non-conforming product hold, as well as potentially affected product.
  • Coordinate inspection and necessary tasks to duplicate failure mode, as well as ES necessary to quality assurance.
  • Follow up on all CAPA tasks are completed in a timely and proper manner.
  • Participate in conference calls, presentations and meetings with plant teams and upper management.
  • This position will 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.
  • Develop Monitor and Trending Investigation Reports for market complaint.
  • Create CCNs and CCRs.
  • Responsible of developing and participate in projects and investigations with its principal intention of improving product’s quality in general, although their participation can be required in savings projects.
  • Be able to develop and implement quality plans, including tracking, analyzing, reporting, and problem solving.
  • Responsible of risk analysis assignation for CAPA’s and NC’s.
  • Assist Regulatory Affairs and Engineering personnel in new product/process design, specifications and changes to assure effective control procedures are established. Participate actively in product and process start-ups.
  • Investigate product’s quality problems, determine root cause, gather and analyze data and implement corrective actions to reduce or eliminate cause.
  • Data analysis of market complaints intended to identify quality problems.
  • Responsible of keeping “complaints goals” quality goals within target.

Requirements:

  • Bachelor’s Degree in Engineering.
  • Bilingual English / Spanish.
  • Excellent interpersonal, verbal and written communication skills.
  • Good technical and analytical skills.
  • Statistical techniques knowledge (Six-Sigma methodology preferred)
  • Knowledge on computing tools
  • Problem solving and root cause analysis
  • Process and Test Method Validations.
  • Experience with Medical Devices.

Responsibilities:

  • Responsible for supporting the development of corrective/preventive actions (CAPA) corresponding to the assigned manufacturing area.
  • Coordinate/lead root cause investigation tasks with investigation team.
  • Coordinate non-conforming product hold, as well as potentially affected product.
  • Coordinate inspection and necessary tasks to duplicate failure mode, as well as ES necessary to quality assurance.
  • Follow up on all CAPA tasks are completed in a timely and proper manner.
  • Participate in conference calls, presentations and meetings with plant teams and upper management.
  • This position will 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.
  • Develop Monitor and Trending Investigation Reports for market complaint.
  • Create CCNs and CCRs.
  • Responsible of developing and participate in projects and investigations with its principal intention of improving product’s quality in general, although their participation can be required in savings projects.
  • Be able to develop and implement quality plans, including tracking, analyzing, reporting, and problem solving.
  • Responsible of risk analysis assignation for CAPA’s and NC’s.
  • Assist Regulatory Affairs and Engineering personnel in new product/process design, specifications and changes to assure effective control procedures are established. Participate actively in product and process start-ups.
  • Investigate product’s quality problems, determine root cause, gather and analyze data and implement corrective actions to reduce or eliminate cause.
  • Data analysis of market complaints intended to identify quality problems.
  • Responsible of keeping “complaints goals” quality goals within target.

Requirements:

  • Bachelor’s Degree in Engineering.
  • Bilingual English / Spanish.
  • Excellent interpersonal, verbal and written communication skills.
  • Good technical and analytical skills.
  • Statistical techniques knowledge (Six-Sigma methodology preferred)
  • Knowledge on computing tools
  • Problem solving and root cause analysis
  • Process and Test Method Validations.
  • Experience with Medical Devices.

Responsibilities:

  • Responsible for supporting the development of corrective/preventive actions (CAPA) corresponding to the assigned manufacturing area.
  • Coordinate/lead root cause investigation tasks with investigation team.
  • Coordinate non-conforming product hold, as well as potentially affected product.
  • Coordinate inspection and necessary tasks to duplicate failure mode, as well as ES necessary to quality assurance.
  • Follow up on all CAPA tasks are completed in a timely and proper manner.
  • Participate in conference calls, presentations and meetings with plant teams and upper management.
  • This position will 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.
  • Develop Monitor and Trending Investigation Reports for market complaint.
  • Create CCNs and CCRs.
  • Responsible of developing and participate in projects and investigations with its principal intention of improving product’s quality in general, although their participation can be required in savings projects.
  • Be able to develop and implement quality plans, including tracking, analyzing, reporting, and problem solving.
  • Responsible of risk analysis assignation for CAPA’s and NC’s.
  • Assist Regulatory Affairs and Engineering personnel in new product/process design, specifications and changes to assure effective control procedures are established. Participate actively in product and process start-ups.
  • Investigate product’s quality problems, determine root cause, gather and analyze data and implement corrective actions to reduce or eliminate cause.
  • Data analysis of market complaints intended to identify quality problems.
  • Responsible of keeping “complaints goals” quality goals within target.

Requirements:

  • Bachelor’s Degree in Engineering.
  • Bilingual English / Spanish.
  • Excellent interpersonal, verbal and written communication skills.
  • Good technical and analytical skills.
  • Statistical techniques knowledge (Six-Sigma methodology preferred)
  • Knowledge on computing tools
  • Problem solving and root cause analysis
  • Process and Test Method Validations.
  • Experience with Medical Devices.
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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