Opportunity Description
**Job Description:**
The Head of Quality Assurance is responsible for Quality Assurance and Quality Control at the production site of Nobel Biocare AB, located in Karlskoga, Sweden. This position ensures the manufacturing site complies with applicable international medical device regulations and standards. A key responsibility will be to lead, maintain, and continuously improve the site Quality Management System (QMS) to guarantee product safety and efficacy. This role focuses on ensuring that production processes remain in a state of control, validations are robust, and processes consistently produce medical devices that meet specifications, Regulatory requirements (ISO 13485 / FDA 21 CFR 820), and patient safety standards.
+ Lead and develop the Quality department consisting of QC and QA
+ Ensure the awareness of applicableRegulatory& QMSrequirements throughout the organization
+ Ensure process risk assessment files are in accordancetoISO 14971
...
The Head of Quality Assurance is responsible for Quality Assurance and Quality Control at the production site of Nobel Biocare AB, located in Karlskoga, Sweden. This position ensures the manufacturing site complies with applicable international medical device regulations and standards. A key responsibility will be to lead, maintain, and continuously improve the site Quality Management System (QMS) to guarantee product safety and efficacy. This role focuses on ensuring that production processes remain in a state of control, validations are robust, and processes consistently produce medical devices that meet specifications, Regulatory requirements (ISO 13485 / FDA 21 CFR 820), and patient safety standards.
+ Lead and develop the Quality department consisting of QC and QA
+ Ensure the awareness of applicableRegulatory& QMSrequirements throughout the organization
+ Ensure process risk assessment files are in accordancetoISO 14971
...
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