Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Quality Initiatives and Continuous Improvement:

• Lead the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
• Drive continuous improvement projects through Practical Process Improvement to ensure the timely and accurate completion of quality projects and tasks.
• Work with management to devise and implement quality strategies and policies.

Audits and Compliance:

• Manage internal audits by plan and coordinate to ensure the internal audit findings are rectified and corrective action is implemented.
• Support external audits and follow up on external audit findings and corrective actions.
• Ensure quality systems and procedures are in compliance with ISO 13485, MDSAP, FDA 21 CFR Part 820 IVDR, IVDR

Quality Management and Data Analysis:

• Provide management with quality data and trends in product performance in meeting customer requirements.
• Review customer complaints and analyze data for trends.
• Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions.
• Review deviation and risk management for products

Quality Assurance and Change Management:

• Participate in the construction of SOPs, review and approve of COs (Change Order) on changes that affect the quality management system.
• Support organization in change management which includes QMS and new product release and changes based on approved and released documentation as defined in respective processes, SOP and project responsibilities.

Support and Special Projects:

• Support plant-wide activities and special projects, as assigned.

Qualification

• Bachelor degree in Science, engineering or equivalent.

Experiences

• Minium 5 years in QA function with people management
• Relevant working experience in quality function dealing with medical devices / IVD devices / ISO13485 environment preferred

Competencies Preferred

• Proactive and assertive attitude.
• Ability to interface effectively in a global matrix organization environment
• Strong communication (verbal and written) and good interpersonal skills with all levels.
• Trained as internal auditor and lead auditor.
• Knowledge of statistical controls and data analysis
• Experience in Process validation activities as Quality function

Skills Required