Total 6 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.

You will collaborate with stakeholders on timely data submissions and accurate reporting of clinical quality indicator results. This involves data extraction and analysis, and maintaining the department’s database. You will also promote and encourage staff participation in quality improvement programmes and contribute to projects relating to Quality Improvement initiatives.

In addition, you will coordinate and support Ensure Safe System (ESS) for Quality Assurance & Risk Management and liaise with ESS stakeholders to ensure standards are met. You will also coordinate meetings, prepare meeting minutes and reports, and provide any other administrative support. You will also work closely with internal/external stakeholders to support corporate programmes and participate in ad hoc operational projects and initiatives.

The selected candidate will be offered employment on 2-year renewable contractual terms.

Job Requirements:

· Degree in Biological Science or Applied Science, with 2 years’ working experience

· Proficient in Microsoft Office applications

· Excellent interpersonal, written and oral communication skills

· Meticulous with good organisational skills and able to work independently

• 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.

Passionate about patient safety and quality (PSQ)? Join us at the Institute for Patient Safety & Quality (IPSQ) where our team is dedicated to designing concepts and initiatives to enhance patient safety.As the Assistant PSQ Lead, you will collaborate with domain experts, manage impactful projects, educate staff on improvement methodology and tools, and publish best practices to enhance patient safety and quality (PSQ).

You will facilitate large-scale sharing and form partnerships/networks/community of practices with clinical domain and industry experts to identify and work towards eliminating potential patient safety risks.Additionally, you will guide project teams to understand the current process, determine goals and measurement indicators to guide improvement and sustain change. You will also be involved in education and training, designing, conducting, and evaluating training programmes, sharing best practices through publication, and managing the cluster improvement portal to encourage project registrations and selecting project ideas that contribute to cluster improvement.

Furthermore, you will be responsible for writing PSQ-related proposals for funding applications, conducting literature reviews, and performing environmental scanning and analysis for insights and trends to identify growth opportunities.

Requirements

• Relevant Postgraduate Master's with at least 3 years of relevant experience and demonstrated competency, or
• Relevant Bachelor’s Degree with at least 5 years of relevant experience and demonstrated competency
• Proven track record in PSQ initiatives and project management
• Strong analytical, organisational, and interpersonal skills
• Experience with data management and statistical analysis
• Demonstrate a commitment to patient safety, quality, and standards, including a dedication to continuous improvement, innovation, and effective communication for collaborations and learning