Engineer, Computer Software Assurance
Beckman Coulter (Danaher)Bellandur, BangalorePosted 24 days agoA free account shows the apply link for every role and matches you to the ones that fit your resume.
About the role
Masimo develops medical monitoring technologies, sensors, patient monitors and connectivity solutions. This engineer will oversee computer system validation for GxP systems and help ensure compliance with medical device regulations.
What you'll do
- Develop and execute CSV strategies, plans and protocols
- Oversee validation of GxP-regulated enterprise and manufacturing systems
- Ensure systems comply with FDA and ISO requirements
- Develop validation documentation, including plans and test reports
Skills
Must have
- Computer system validation
- 21 cfr part 11
- 21 cfr part 820
- Iso 13485
- Iso 14971
- Gamp5
- Risk-based software validation
- Data integrity
- Validation documentation
Nice to have
- Eu mdr
- Annex 11
- Iso 27001
- Cloud-based system validation
- SAAS validation
- Fda inspection support
- Qms process improvement
Who it's for
- Experience
- 5+ years
- Domain
- medical technology
About Beckman Coulter (Danaher)
Beckman Coulter (Danaher) has 52 open roles in Bangalore, at Beckman Coulter Indian Development Centre. See every Beckman Coulter (Danaher) role.
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