Straumann·12 days ago
12 days ago
Operations Quality Engineer
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What you'll do
- Support and implement validation and quality systems to ensure compliance with ISO and FDA standards
- Plan and execute equipment and process validations
- Collaborate with cross-functional teams
What they're looking for
- Experience in medical device manufacturing
- Strong understanding of quality principles
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Become part of our team as an Operations Quality Engineer, supporting and implementing validation and quality systems to ensure compliance with ISO and FDA standards. You will plan and execute equipment and process validations, and collaborate with cross-functional teams. Ideal candidates have experience in medical device manufacturing and a strong understanding of quality principles.
Skills
- equipment validation
- process validation
- risk management
- iso 13485
- capa
- root cause analysis
- design control
- non-conformance management
- quality management systems
- medical device regulations
- fmea
- spc
- rca
- fishbone analysis
- pareto analysis
- process mapping
- flow charts
- audit management
- quality documentation
- medical device manufacturing
- cross-functional collaboration
- training delivery
- microsoft office
- six sigma
- lean manufacturing
Company
Straumann
Round Rock (TX), United States of America
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