Engineering
Design Quality Assurance Expert
Address: No.1,Tengfei Road, Guli Industrial Park, Changshu, Changshu, Jiangsu, 215533, China
Job ID: R0260768
Location Type: Hybrid
- 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
Introduction section
At Fresenius Medical Care, we are the world's leading provider of products and services for individuals with renal diseases. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 112,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:
• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation
Information about plant:
At our Changshu plant in China, we manufacture life-sustaining products that support dialysis patients around the world. Our portfolio includes dialyzers, bloodline sets, dialysis solutions, hemodialysis machines, and key medical components. Using advanced technologies such as injection molding, extrusion, and automated assembly, our teams help ensure the highest standards of quality and reliability. Join us and become part of a global team committed to creating a future worth living for patients worldwide.
Design Quality Assurance Expert
Role&Responsibilities:
- Ensure design quality compliance of medical device design and development activities throughout the product lifecycle. Act as the Design Quality representative within cross-functional project teams, providing oversight of design controls, design transfer and design change activities in accordance with applicable regulations, standards, and internal procedures.
- Ensure compliance of design and development activities with regulatory, quality, and design control requirements.
- Represent Design Quality in product development, design transfer and design change projects.
- Review and approve design control deliverables, Design History File (DHF) documentation, and project milestones.
- Support preparation of documentation required for regulatory submissions and technical files.
- Participate in Design Reviews, Phase Exit Reviews, and compliance assessments.
- Provide training and guidance on design control and quality requirements.
- Review and approve Design & Development-related NCs, CAPAs, and change controls.
- Conduct audits and compliance checks to ensure adherence to the Quality Management System (QMS).
- Support design transfer activities and collaboration between R&D, Regulatory Affairs, and Manufacturing.
Job Requirements
- 10 years’ experience in medical device is desirable
- Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
- Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
- Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
- Knowledge of CAPA methodology
- Basic Knowledge in statistical methods
- Good in stakeholder management and communication
- Understands balance between business needs and product quality & regulatory requirements
- Trusted quality partner in cross-functional project meetings
- Cross functional leader managing on site design quality aspects on local level and well connected to global level
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
By submitting your information, you acknowledge that you have read our privacy policy consent to receive email communications from Fresenius Medical Care AG.