Operate in close collaboration withproduction and assure a timely handling of all quality relevant topics andcompliance with current FDA, EMEA regulations and ISO 13485.
Assure that all intermediate andfinal products manufactured in Majorenacker site for Production Medical Devices(PMD) meets requirements according to ASP specification and current guidelines.
Assure that quality systems such asdeviation system and change control system are consistently followed.
Escalate any issues which may impacton the compliance status or product quality of STERRAD products.
Batch disposition on product releasethrough entire manufacturing and packaging process
In time Batch Record review and release for STERRAD products
Batch release of semi-finished and finished goods .
In time processing of STERRAD products Complaint
In time processing of NCs, and Complaits for STERRAD products.
Compliance to GMP, EHS and SOX specifications and guidelines associatedwith each function.
Construction and review of qualitydocuments (e.g. SOPS, Q-Agreements etc.)
Support and assess changes in areaof responsibility
Filing and archiving of Batch documentation and samples.
Procurement for Quality Business UnitNCsand complaints handling
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
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.