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 Systems Engineer 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 :
Collect relevant site QMS data from various sources for Quality Monitoring.
Participates in the implementation and maintenance of the quality systems program; promotes and facilitates continuous quality improvement.
Ensures quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
Develops and implements measures to monitor effectiveness, metrics and Quality System process improvements.
Develops, maintains and reports site quality metrics related to compliance, effectiveness and resolution of issues.
Supports Quality System Lead to manage the site Corrective and Preventive Action (CAPA), Non-conformances (NC) and audits to ensure effectiveness and efficiency.
Leads cross-functional activities related to Quality Systems and represents Quality Systems on project teams such as Learning Management program
Oversee and manages the site Quality Audit schedule and conducts internal audits as subject matter expert (SME).
Provides support for regulatory inspections of quality management systems as subject matter expert (SME).
Other duties may need to be performed as assigned.
Here’s what we’ll need from you :
Minimum Requirements :
Minimum Bachelor’s degree in Engineering, Life Sciences, or Physical Sciences
3+ years’ experience in medical device, pharmaceutical or other highly regulated industry
Good working knowledge (with the ability to interpret, apply and implement) of applicable regulations and standards such as FDA QSR (21 CFR 820), MDR, MDSAP and ISO 13485.
A minimum of 3+ years Quality Systems experience in medical device or pharmaceutical industry with previous supervisory experience.
Strong written and verbal communication skills.
Fluent in German and English language.
Experience in Microsoft Office programs (PowerPoint, Excel, Word, and Outlook).
Critical thinking skills in analyzing and exercising judgement on complex issues, guided by a thorough understanding of quality philosophy.
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.
Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
Able to gain cooperation of others.
Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
Able to make and prioritize process and resource decisions based on overall team needs.
Experience supporting 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit)
Preferred Skills :
Qualified Quality Systems Lead Auditor.
Six Sigma Process Excellence Green or Black 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.