Description
Medical Devices Company in Switzerland, Zurich area - is searching forSENIOR QA/RA SPECIALISTS
positions are open for a freelance consultant and a permanent candidate.
Please apply if you are available now or very soon.
The freelance candidate should be available 100% on site
The permanent candidate should be living in the Zurich area and available soon or within 6 months.
DESCRIPTION
This position will report to the Vice President of Quality Management and Regulatory Affairs and be responsible for managing and improving the Company's Quality System and Regulatory Affairs activities including the registration of submissions leading to market clearance or approval. Key responsibilities will be leading and managing the Company's complaint handling process as the key interface between the customer, the commercial and engineering teams and managing the manufacturing quality control processes and procedure improvements.
KEY RESPONSIBILITIES
* Manage manufacturing product quality for both internal and external manufacturing facilities
* Perform internal and external customer audits and participate in Notified Body and FDA audits
* Improve and manage the customer complaint handling process, including logging complaints, communicating with customers to establish a full understanding of the issues, working with applicable individuals and departments to ensure complaint handling time requirements are met and performing and writing complaint investigations
* Tracking & trending of customer complaints and reporting for management review
* Analyzes trends in data for the purpose of initiating corrective actions
* Manage NCMR, CAPA and PCAR process with a focus on root cause analysis
* Responsible for capturing records of MRB, CAPA, and other QA review meetings
* Creation and maintenance of Design Dossiers and Technical Files
* Management of CE-Certification process, Major and Minor Change Notifications and Risk Analysis
* Determination of MDR and Vigilance reportability
REQUIRED SKILLS / EXPERIENCE
* BS/BA in Engineering or Life Sciences, Master's Degree preferred
* Minimum of 5 years of related QA/RA medical device experience
* Deep knowledge of Quality and Regulatory Principles
* Thorough understanding of statistical data analysis tools and techniques
* Competency in generating written technical reports for management review
* Demonstrated ability to develop a "hands-on" approach, requiring personal initiative and responsibility while operating at a high level of performance and efficiency
* Ability to work in a timeline driven environment
* Ability to lead effective meetings and make independent decisions in-line with Company objectives
* Proven leadership qualities, including team building skills, to facilitate completion of tasks
* Strong Interpersonal, oral and written communication skills
* Proficiency in German and English
Please respond stating relevant details as:
- Perm or Freelance interest
- earliest availability (Date/ notice period for permanent/ % for freelance)
- Salary expectations / hourly rate
- please add your current CV in Word Format
Please be so kind and provide me with this details as they will help me to manage the process more quickly and I will get back to you shortly.