The Quality Assurance specialist role is responsible for quality oversight and QA support on site ensuring compliance with procedures, specifications and GMP requirements.
This includes support in quality improvement projects, change initiatives and non conformance investigation.
Daily business is the review of batch records ensuring on time release of products and the processing and support of complaint investigation.
Intensive collaboration with the production and engineering areas for quality topics and working with the global ASP team is required.
Operate in close collaboration with production and assure a timely handling of all quality
relevant topics and compliance with current FDA, EMEA regulations and ISO 13485.
Assure that all intermediate and final products manufactured in Majorenacker site for Production
Medical Devices (PMD) meets requirements according to ASP specification and current
Assure that quality systems such as deviation system and change control system are
Escalate any issues which may impact on the compliance status or product quality of STERRAD
Batch disposition on product release through entire manufacturing and packaging process
Review and Approval of SAP master data including recipes, BOM, DMD / AGG codes and etc.
In time Batch Record review and release for STERRAD products
Batch release of semi-finished and finished goods (Autorelease by SAP).
In time processing of STERRAD products Complaint
In time processing of NCs, and Complaints for STERRAD products.
Compliance to GMP, EHS and SOX specifications and guidelines associated with each function.
Construction and review of quality documents (e.g. SOPS, Q-Agreements etc.)
Owned Change Owner function and assess changes in area of responsibility
Filing and archiving of Batch documentation and samples.
Procurement for QA Business Unit
Creation of product certification in eLIMS
Download, edit and enter scorecards data, trend reports and governance processes
NCs and complaints handling
Represents the staff QA specialist in the quality department regarding STERRAD
High level of quality mindset for all tasks. Strong analytical thinking.
Experience working in GMP regulated industries
Experience in Nonconformance investigations, CAPAs and complaint investigations
Experience with change controls
Capable to of creating and revising work instructions and procedure
Strong written and verbal communication skills
Fluency in German and English written and verbally
Experience with electronic quality systems
Experience supporting 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit)
Minimum Bachelor’s degree in Engineering, Life Sciences, or Physical Sciences
3-5 years experience in highly regulated industry preferred
Medical Device industry experience (FDA and ISO 13485) preferred
Practiced in MS Office products
Experience with SAP
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. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry.
With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities.
Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.