Quality Assurance Manager

JOB DESCRIPTION:

• Develop and implement quality assurance strategies, policies, and procedures to meet customer expectations and regulatory requirements.
• Manages, steers, and develop to sustain Toyoflex Cebu’s Quality Management System in line with the required standards (ISO 9001: 2015 / ISO 13485:2016) accreditation, and business requirements across organization.
• Ensures that all in-house systems and procedures are updated, revised and modified to meet organization’s needs, customers, and external certification bodies.
• Undertake internal and process audits of the QMS to validate system and process compliance.
• Verify closure of non-conformities and ensure corrective actions are undertaken to address issues found.
• Provide analysis of nonconformities and hold regular audit performance meetings with QMS Team.
• Ensure that all necessary systems and procedures are in place to satisfy customer requirements and audits.
• Take lead in setting the team direction to develop new system supporting QA Management solutions, quality data processing and automation tools for data collection.
• Ensure QA System compliance to existing regulations and guidelines governing software validation.

JOB QUALIFICATIONS:

• Bachelor’s degree of any Engineering course; a license Engineer or Master’s degree is a plus.
• Certifications such as Lean Six Sigma, PMP (Project Management Professional), Lean Manufacturing or specific industry-related certifications can be advantageous. Expertise in process improvement methodologies such as Six Sigma and Lean principles
• Working knowledge on Quality Management Systems (ISO 9001 / ISO 14001 / ISO 13485)
• Strong understanding of engineering principles and practices.
• Knowledge of statistical tools and software for quality data analysis.
• Knowledgeable in Quality document processing system and manuals, records processing and internal audit
• Excellent verbal and written communication skills
• Possess good technical skills in a manufacturing company
• Must possess good organizational, time management skills and leadership skill with the ability to delegate, organize and manage a team effectively
• Ability to work well in a team environment and collaborate with other departments
• At least 5-10 years work experience in quality assurance, quality control, or a related field