Total 4 quality assurance job vacancies in d03 queenstown tiong bahru

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

• Oversees audit planning, field work, and audit reporting; prepares reports, and communicates findings and recommendations to management.
• Review audit work papers prepared by the audit staff to ensure compliance with the firm's audit methodology.
• Responsible for the daily supervision of audit staff and responsible for the development of audit staff and the completion of performance evaluations.
• Excellent communications skills, strong analytical and problem solving skills.
• Technically-sound and committed with good positive working attitude.
• Able to perform under pressure in fast-paced working environment.

• Managing audit engagements which include initial engagement planning, analysis of controls and processes, preparation and review of audit documentations.

• Drafting of management letters and financial statements.

• Monitoring of engagement progress against budget and timeline set.

• Excellent communications skills, strong analytical and problem solving skills.

• Possess strong passion and desire to grow and improve technically and professionally.

• Committed with good positive working attitude.

• Able to perform under pressure in fast-paced working environment.

• Perform various tests according to firm's audit workflow/methodology.

• Assist in completing engagements in timely and orderly manner.

• Good communication skills and an eye for detail.

• Possess strong passion and desire to grow and improve technically and professionally.

• Committed with good positive working attitude.

• Able to perform under pressure in fast-paced working environment.