Site Quality Leader

Job Responsibilities:

• The Quality Assurance Manager is designated by Top Management as the Site Quality Management Representative with overall responsibility for product quality, compliance to applicable standards and championing a culture of quality within the site.

• Establishes operational objectives and work plans, delegates assignments to subordinates to ensure smooth execution and efficient distribution of tasks within the organization and fosters collaboration and productivity while aligning with overarching goals.

• Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.

• Utilizes wide-ranging experience and professional expertise, creatively resolves complex issues aligned with company objectives, distinguished by additional specialized knowledge and recognized as an expert in the field.

• Guides the review and approval of finished products manufactured for and by the company, manages all inspections and inquiries regarding the operation of manufacturing sites and collaborates with relevant company groups to ensure compliance with company standards, regulations and approved manufacturing process specifications.

• Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.

• Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.

• Owns audits, and assessments processes, supports in external and internal audits, aides in regulatory compliance gap closure, monitors supplier quality metrics, and participates in supplier quality-related communication and feedback.

• Champions programs to improve Quality, Compliance and overall departmental productivity and efficiency.

Minimum required Education:

Bachelor's / Master's Degree in Quality Management, Supply Chain Management, Engineering discipline, Science or equivalent.

Minimum required Experience:

Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent.

Preferred Skills:

• Quality Assurance (QA)

• Quality Management Systems (QMS)

• Continuous Improvement

• Quality Control Inspection

• CAPA Methodologies

• Quality Management Procedures and Methodologies

• Supplier Quality Management

• People Management

• Risk Management

• Strategic Planning

• Regulatory Compliance

• KPI Management

• Budget Management

• Business Acumen

• Working knowledge of applicable international standards such as ISO13485, ISO9001, ISO14971