As Quality Manager you will act as Deputy for the Head of Quality Compounding Devices (Quality Management Representative) and report to him. In this role you will ensure compliance in Development Projects incl. Risk Management.
Further responsibilities:
- Quality Approver for Events, Complaints, CAPAs and Change Controls
- Execution of Incoming Goods Inspection and preparation of batch & device release documentation
- Preparation, monitoring and support of audits and inspections (internal and external)
- Collection and Preparation of Quality Key Performance Indicators
- Review, Update and (if necessary) Approval of SOPs and WIs incl. Training
- Support or execute investigations / Root Cause Analysis and related definition of actions
- Support Risk Management activities, Qualifications & Validations and Supplier Quality Management
Your profile
- Graduate degree in engineering in the field of electrical engineering, mechanical engineering, medical technology or similar
- Several years of experience in Medical Device Industry (R&D, Manufacturing, Quality Control), Supplier Quality Management and Quality Assurance
- Very good knowledge of ISO 13485, ISO 9001 and ISO 14971
- Founded knowledge of the GMP regulations and the regulation 21 CFR Part 820
- Experience with TrackWise (Sparta System) and Auditing (certification as Lead Auditor is a plus)
- Fluent English and German, both written and spoken
- Structured, pragmatic and self-reliant way of working
Your benefits
Career with a Purpose
With your job, you make a valuable contribution to improving patients' quality of life around the world.
Long-term Account
Whether it's training, caring for family members, early retirement or a period of absence - the long-term account offers various time-off options.
Pension Plan
At Fresenius, you receive an employer-funded company pension plan in addition to your salary.
Childcare Allowance
If you have children, you can apply for a financial allowance which is transferred monthly in addition to your salary.
Health at Work
We offer you a wide range of sports, nutrition trainings and preventative services.
Direct Insurance
Fresenius supports you in setting up your direct insurance – so you can benefit from the attractive conditions of our Group agreement.
Accident Insurance
At Fresenius, you are covered for accidents every day of the year, anywhere in the world. In addition, you can also insure your family.
Individual Professional Development
We promote you with professional development programs and support lifelong learning throughout your career.
Employee Discounts
We offer you to benefit from a program with attractive discounts on products and services from well-known retailers.
Corporate Catering
Our company restaurants provide you with freshly prepared meals every day.
Food Allowance
You can purchase food and drinks at a discounted price in our company restaurants.
Company Medical Service
The company medical service is available for consultation, first aid in the event of occupational accidents or reintegration.
Transport Connection
Most of our locations are very well connected to highways, bus stops or train stations.
Parking Lots
Free parking lots are available at many of our locations.
Sports Activities
Depending on the location, we offer a wide range of sports activities - from company runs and sports badges to tournaments and competitions.
Hybrid Working
Working from home or in the office or both? There are various offers for hybrid working that give you a lot of flexibility.
Employee Participation Program
With Fresenius SHARE, we let our employees participate in the company's performance through a share program; in addition, we enable them to buy shares at very favorable conditions.
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At a glance
Location:
HessenBad Homburg
Career level:
Professional Experienced
Job function:
General EngineeringQuality Management
Employment relationship:
PermanentFull-time
Division:
Fresenius Kabi
Reference number:
59186
Publishing date:
03/20/2024
As long as the job ad is online, you can apply quickly and easily.
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Your contact
Sandra Raickovic
Fresenius Kabi Deutschland GmbH
Bad Homburg
We welcome diversity
At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.
All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).
Careers with a purpose
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.