Job Description
About the Role
We are looking for a Quality Engineer to ensure compliance with medical device quality standards and drive supplier performance improvements. This role involves supplier audits , risk management , and quality system assessments to meet global regulatory requirements.
Key Responsibilities
Plan and conduct supplier quality system assessments , including preparation, scheduling, and follow-up actions
Assess supplier capabilities through site visits , technical discussions , and quality audits
Prepare detailed assessment reports and communicate quality issues to suppliers, driving corrective actions
Collaborate with corporate and regional quality teams on policy and guideline development
Track and trend supplier performance , implement remedial actions, and maintain ERP vendor profiles
Support suppliers in statistical sampling plans , inspection methodology , and quality procedures
Ensure compliance with ISO 13485 , 21 CFR Par...
We are looking for a Quality Engineer to ensure compliance with medical device quality standards and drive supplier performance improvements. This role involves supplier audits , risk management , and quality system assessments to meet global regulatory requirements.
Key Responsibilities
Plan and conduct supplier quality system assessments , including preparation, scheduling, and follow-up actions
Assess supplier capabilities through site visits , technical discussions , and quality audits
Prepare detailed assessment reports and communicate quality issues to suppliers, driving corrective actions
Collaborate with corporate and regional quality teams on policy and guideline development
Track and trend supplier performance , implement remedial actions, and maintain ERP vendor profiles
Support suppliers in statistical sampling plans , inspection methodology , and quality procedures
Ensure compliance with ISO 13485 , 21 CFR Par...
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