At Fortive, we believe in you. We believe in your potential your ability to learn, grow, and contribute in meaningful ways.
We believe in the power of great people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own.
The Quality System Analyst role is responsible for supporting the implementation and maintaining the effectiveness of the Quality System and to assure ASP products fulfill their quality and regulatory requirements :
Maintains the document management system for issuance recording, filing, tracking, retrieval of documents like procedures, plans, QA records, specifications and related documents.
Contribute to the development, maintenance, and improvement of Quality System documentation (e.g. SOPs, Work Instructions, Forms, Templates) to increase the efficiency and effectiveness of the QMS.
Provide Document Control (EZDoc) support to authors and (local) process owners in defining and producing lean Quality System documents and records;
ensure proper quality of the content of documentation and records.
Serve as key contributor to QMS business process(es) engaging in the development of best in class QMS processes.
Support QMS related forums (e.g. Management Review) through data preparation and analysis.
Function as training coordinator, routing tasks to appropriate personnel and keeping workflows running efficiently. Ensure all mandatory training requirements are set and controlled and training is executed as required.
Coordinate the training program to ensure all employees have the correct training tasks assigned.
In close cooperation with functional managers ensure the assignment of the correct training profiles to all individual employees based on job requirement profiles, administer both profiles and training records in line with requirements and support users on using the Learning Management program.
Establish, monitor and respond to metrics on the efficacy and efficiency of the document management and training management systems and their ability to support the business
Other duties may need to be performed as assigned.
Provides support for internal audit and regulatory inspections of quality management systems as subject matter expert (SME).
Support other quality system components as necessary (including documentation related to deviations, CAPA, and change control).
Support internal and external quality system audits.
Here’s what we’ll need from you :
Minimum Requirements :
Minimum Bachelor’s degree in Engineering, Life Sciences, or Physical Sciences.
2+ years’ experience in medical device, pharmaceutical or other highly regulated industry.
Working knowledge (with the ability to interpret, apply and implement) of applicable regulations and standards such as FDA QSR (21 CFR 820), MDR and ISO 13485.
A minimum of 2+ years Quality Systems experience in medical device or pharmaceutical industry with previous supervisory experience.
Good written and verbal communication skills.
Fluent in German and English.
Experience in Microsoft Office programs (PowerPoint, Excel, Word, and Outlook).
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.
Able to gain cooperation of others.
Preferred Skills :
Qualified Quality Systems Lead Auditor.
Six Sigma Green Belt Certification.
Fortive Corporation Overview :
Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose : to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress.
Here, you get the excitement of a startup with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth.
There’s no limit to what you can learn, or the impact you can make : for you, for us, for growth.