Senior Quality Assurance Engineer & Compliance Lead

SUNNINGDALE TECH LTD.; Singapore; In loco; SGD 52.000 - 78.000; Tempo pieno

Descrizione del lavoro

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components seeking a Quality Assurance leader to oversee daily quality activities, participate in new product development, and ensure compliance with GMP, GDP, and ISO13485.

You will lead a team of inspectors and technicians, drive CAPA closure, analyze KPIs, and collaborate with cross-functional teams to maintain high quality standards for customers worldwide.

Competenze

• Diploma or degree in Engineering or equivalent.
• Strong analytical thinking, problem solving and leadership.
• Ability to work in a growing, fast-changing environment.
• Knowledge in ISO13485 is an added advantage.
• Good written and oral communication skills.

Mansioni

• Oversee the daily quality activities including involvement in new project development with relate to technical and non-technical operations.
• Resolves customer inquiries, quality, and operational issues in a timely manner by consulting with the Business Development HOD, Operation Manager, QA Manager, other supporting managers, Superior.
• Manage, lead, and motivate a team of quality inspectors and technicians to meet departmental objectives and goals, create and promote food safety, GDP, GMP& lead by example.
• Early involvement in new product and project development to establish internal specification and keep abreast of customer requirements.
• Document in STL's quality system and implement programs to ensure compliance with applicable regulatory requirements and corporate's quality system requirements.
• Develop and continually improve production, inspection and process control activities, corrective & preventive action, hazard analysis and risk management.
• Responsible for timely closure of CAPA, non-conformance investigation report, customer complaints and deviations. Escalate to superior if required
• Analyse and trend various Key Performance Indicators per management's vision and direction, including indicator of interest.
• Develop, reviews, and approves qualifications and validation protocols, involvement in food Hazard/Medical device Risk management activities and departmental level risk and opportunity assessment, including JSA.
• Ensures effective communication internally & externally.
• Ensure department's personnel competency, develop, and retain skill base knowledge within the organisation, through training needs identification.

Conoscenze

Analytical thinking

Problem solving

Leadership

Communication skills

Formazione

Diploma/Degree in Engineering

Strumenti

Quality tools

Descrizione del lavoro

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components seeking a Quality Assurance leader to oversee daily quality activities, participate in new product development, and ensure compliance with GMP, GDP, and ISO13485.

You will lead a team of inspectors and technicians, drive CAPA closure, analyze KPIs, and collaborate with cross-functional teams to maintain high quality standards for customers worldwide.