Key Responsibilities:
1. Drive Consistent Excellence in Final Product Quality
Conduct in-process and final product inspections to ensure product conformance.
Manage product testing calibration and validation processes.
Investigate product deviations and implement corrective and preventive actions
(CAPA).
2. Quality Systems & Process Control
Establish implement and maintain Quality Management Systems (QMS) in
compliance with ISOCE FDA and other regulatory standards.
Define and monitor quality control checkpoints across the production process.
Drive continuous improvement in quality and process reliability.
3. Supplier Quality Management
Evaluate and audit suppliers to ensure compliance with company quality standards.
Work closely with procurement and production teams to resolve quality issues
related to materials and components.
4. Documentation & Compliance
Prepare and maintain all quality-related documentation reports and audit trails.
Ensure compliance with regulatory and certification standards (ISO 9001 ISO 13485
CE FDA etc.).
Lead internal and external audits with certification and regulatory bodies.
5. Cross-Functional Collaboration
Work closely with R&D Production and Operations teams to implement quality best
practices.
Support the product team in defining specifications and quality criteria during design
and development.
Requirements:
Bachelors degree in Engineering Quality or related technical field.
3 5 years of experience in Quality Assurance / Quality Control in a product
manufacturing or health-tech company.
Hands-on experience with QMS implementation ISO standards CAPA and audits.
Strong understanding of quality tools such as FMEA Root Cause Analysis and 5
Whys.
Excellent analytical documentation and communication skills.
Attention to detail with a problem-solving mindset.
Key Responsibilities: 1. Drive Consistent Excellence in Final Product Quality Conduct in-process and final product inspections to ensure product conformance. Manage product testing calibration and validation processes. Investigate product deviations and implement corrective and prevent...
Key Responsibilities:
1. Drive Consistent Excellence in Final Product Quality
Conduct in-process and final product inspections to ensure product conformance.
Manage product testing calibration and validation processes.
Investigate product deviations and implement corrective and preventive actions
(CAPA).
2. Quality Systems & Process Control
Establish implement and maintain Quality Management Systems (QMS) in
compliance with ISOCE FDA and other regulatory standards.
Define and monitor quality control checkpoints across the production process.
Drive continuous improvement in quality and process reliability.
3. Supplier Quality Management
Evaluate and audit suppliers to ensure compliance with company quality standards.
Work closely with procurement and production teams to resolve quality issues
related to materials and components.
4. Documentation & Compliance
Prepare and maintain all quality-related documentation reports and audit trails.
Ensure compliance with regulatory and certification standards (ISO 9001 ISO 13485
CE FDA etc.).
Lead internal and external audits with certification and regulatory bodies.
5. Cross-Functional Collaboration
Work closely with R&D Production and Operations teams to implement quality best
practices.
Support the product team in defining specifications and quality criteria during design
and development.
Requirements:
Bachelors degree in Engineering Quality or related technical field.
3 5 years of experience in Quality Assurance / Quality Control in a product
manufacturing or health-tech company.
Hands-on experience with QMS implementation ISO standards CAPA and audits.
Strong understanding of quality tools such as FMEA Root Cause Analysis and 5
Whys.
Excellent analytical documentation and communication skills.
Attention to detail with a problem-solving mindset.
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