Quality

Product Center Manager (m/f/d)

Address: Frankfurter Str. 6-8, St. Wendel, 66606, Germany

Job ID: R0230590

Location Type: Hybrid

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  • Overview
  • Job Description
  • Success Profile
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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

In your role as Product Center Manager (m/f/d) you support the Product Center & Risk Management organization and activities thereof, for new and mature products, enabling proper and timely project execution and managing product life cycle across all global markets, with the target to constantly deliver safe, efficient and compliant products of the highest quality standard.

The role ensures timely interaction, preparation and submission of deliverables needed for products implementation in different markets supporting marketing and regulatory strategy and provide substantial support and coordination for products life cycle auditing activities of external Bodies.

Your assignment:

  • Enabling proper projects execution and managing products life cycle across all global markets
  • Establish efficient and effective interfaces to assure fast global market access and business needs
  • Oversee the capacity/competence management and prioritization of Product Center activities in line with the Value Stream strategic priorities
  • Request pro-actively applicable SQR resources and competences according an established Value Stream product roadmap
  • Trigger timely involvements of relevant functions for new product development and major design changes
  • Identify, quantify and communicate quality related project risks within new product developments and lifecycle management
  • Develop, deploy and monitor performance to applicable KPIs (Key Performance Indicators)
  • Ensure new external regulatory intelligence, from the medical device market and regulatory authorities, is understood, forwarded and translated for the Value Stream needs (into applicable processes and products as required)
  • Communicate/collaborate to ensure the Product Center is a trusted partner with all relevant functions to achieve effective regulatory compliance
  • Develop and foster a culture of continuous improvement and process optimization, sharing best practices 
  • Monitor, report and react to quality performance, covering the full Value Stream product portfolio, active and non-active medical devices as well as medical device systems (Ecosystem) including Digital products and services (as far as applicable)

Your profile:

  • Bachelor degree with a Technical/Engineering/Scientific background
  • Minimum of five years professional experience in the field of Regulatory or Quality Assurance Medical Devices / Medicinal Products
  • Knowledge in the field of development and/or manufacture and control of Medical Devices and Medicinal Products
  • Advanced knowledge of applicable quality management and of risk management standards (e.g. ISO13485, ISO14971, EU Guidelines for GMP, IFDA 21 CDR §820.250, etc.)
  • Advanced knowledge of medical device regulations (MDD 93/42/EEC, MDR 2017/745, etc.)
  • Experience in Project Management
  • Knowledge of Quality Management System requirements and main related processes
  • Knowledge of medical products field and application, preferably dialysis and related therapies
  • Fluent in English

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

We've got your back.

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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