Quality
Quality & Regulatory Specialist
Address: Djupdalsvägen 1, Stockholm, Stockholms län 192 51, Sweden
Job ID: R0222387
Location Type: Onsite
- Overview
- Job Description
- Success Profile
- Rewards
- Connect
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.
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.
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.
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.
Job Description
At Fresenius Medical Care, we’re dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments. Our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—guides everything we do. With over 125,000 people working across 3,700 dialysis centers and 39 manufacturing sites worldwide, we provide direct patient care through our Care Delivery network, develop and supply medical products, therapies, digital solutions via Care Enablement, and accelerate transformation through our FME Reignite strategy. Our values drive us:
We Care for our patients, each other, and our communities.
We Connect across teams and borders to deliver excellence together.
And we Commit to doing things the right way, growing with purpose, and leading kidney care with innovation and compassion.
As part of this commitment, Systems, Quality & Regulatory (SQR)—a global function within Care Enablement—ensures product quality and safety, regulatory compliance, and market access throughout the entire product lifecycle. The team drives quality across manufacturing and supply chain processes, manages post-market surveillance, and promotes continuous improvement, system harmonization, and sustainability. SQR also oversees Q&R data governance and delivers key product-related business services. Join our passionate team and help shape healthcare worldwide!
The holder of this position is a member of Q&R Hub EMEA North especially responsible to:
- Implementation and maintenance of local Quality Management System for Medical Devices and medicinal products according to EU and local regulations in cooperation with the Nordic and BeNeLux Quality Team.
- Establishing, implementation, maintenance and improvement of processes. Align processes cross-functionally and within the Nordics & Benelux to create a common, logical and efficient flow to ease the role’s performance.
RESPONSIBILITIES:
- Implementation and maintenance of the local Quality Management System in cooperation with the Nordic and BeNeLux Quality Team.
- If applicable, modification / adaption of Corporate requirements according to national / local needs.
- If applicable, creation of local instructions according to national requirements.
- Establishing, implementation, maintenance and improvement of processes.
- Tracking of CAPA.
- Maintenance of a documentation management system.
- Assist Quality Manager and Responsible Person (RP) as contact partner for audits by the Notified Body, Health Authorities or Corporate functions.
- Contact partner for information to be given to national competent Authorities (FSCA, Recall, etc.) in cooperation with Nordic Quality Team and RP.
- Tracking, follow up and closure of complaints via QTrack. Share applicable information with Quality Manager and RP.
- Preparation of Management Review in cooperation with the Nordic Quality Team.
- Qualification and maintenance of critical suppliers, in cooperation with Procurement, Nordic Quality Team and RP.
- Training activities, e.g. Quality introduction for new employees.
- Performance of self-inspections/internal audits in cooperation with Nordic Quality Team.
- Monitoring of national requirements for medical devices.
REQUIREMENTS:
- Scientific education such as Degree in Medicine, Pharmacy, Biology, Chemistry or similar.
- 2- 5 years of professional experience in quality management of medical devices or medicinal products respectively similar activity in the regulated environment.
- Communicative, reliable, careful, conscientious, quality minded, detail oriented, solution-oriented, proactive, analytical and problem-solving skills;
- Highly professional attitude characterized by a result, quality, patient and customer oriented working style.
- Functional knowledge of Structure of Quality Management System, ISO 9001 / ISO 13485, MDR, Good Distribution Practice (GDP)
- Microsoft Office, QTrak, skills
- Fluent Swedish and English
- Good regulatory understanding
- Good communication skills
Our Offer for you:
There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company
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.
Leadership
Communicator
Compassionate
Problem-solver
Motivational
Good Listener
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.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
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.
Communicator
Compassionate
Detail Oriented
Relationship Expertise
Facilitator
Leadership
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.
Compassionate
Flexible
Independent
Quick-thinking
Patient
Responsible
“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
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
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
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
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.
Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving
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