€52,100.00 - €79,475.00 eur annual; not specified;...
Fully remote
Iso 13485 compliance knowledge
Equipment and software validation
Root cause analysis and capa
This role ensures regulatory compliance and technical excellence for medical device production and cleanroom areas at a global leader in health technology
Job Summary
This role ensures regulatory compliance and technical excellence for medical device production and cleanroom areas at a global leader in health technology.
The successful candidate will lead validation strategies, manage calibration programs, and serve as a subject matter expert for internal and external audits.
BD offers a collaborative culture with opportunities to shape the future of healthcare while working on-site in Heidelberg with high standards.
Matching Summary
This role ensures regulatory compliance and technical excellence for medical device production and cleanroom areas at a global leader in health technology.
Salary
€52,100.00 - €79,475.00 EUR Annual; Not specified; Competitive package with benefits
Skills & Requirements
Must-have
ISO 13485 compliance knowledge
Equipment and software validation
Root cause analysis and CAPA
Process FMEA organization
SAP QM/PM experience
Power BI data visualization
Nice-to-have
TrackWise or MasterControl experience
Six Sigma tools expertise
Strong German and English skills
High frustration tolerance
Project management independence
Key Requirements
Degree in Biotechnology, Microbiology, Chemistry, or Food Technology
Minimum 3 years QA experience in regulated industries