Total 2 qa specialist job vacancies in Singapore

DxD Hub QARA Team is seeking candidate to join the QARA team to support QMS implementation in design and development of software as medical device.

Candidate will receive training in the following areas:

• Understanding concept of ISO 13485:2016 standard and the impact of the requirements on lab operations.
• Management of Change.
• Management of deviation and nonconformity.
• CAPA and root cause analysis.
• Key concepts in IEC 62304/ISO 14971/IEC 62366.
• Software life cycle.
• Software safety classification.
• Conducting risk assessment and usability engineering study.
• Documentation requirements in software design and development .

Candidate will be supporting the QA and lab operations team in the following:

• Provide QA support to the software development team in their design and development activities.
• Participate in audit, when applicable.
• Raise NCR, conduct CAPA process.
• Draft/review software validation protocol/report .
• Draft/review project document.
• Other QA operations role, for example, drafting and reviewing SOP, material inspection.
• Assist in cross division work on ad hoc basis.

Job Requirements:

• Bachelor’s degree in Science or Engineering. Candidates with no experience may apply.
• Basic knowledge in programming.
• Working knowledge in Microsoft office.
• Good communication and presentation skill.
• Individual who is organized, highly motivated and results driven.
• Possesses intellectual agility and a strong team player.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

DxD Hub QA/Lab Operations Team is seeking candidate to join the team to build capabilities needed for lab operation in medical device organization.

You will join the QA and Lab Operations team to implement QMS requirement and laboratory safety protocols in the management of equipment, facilities and inventory within the product development laboratory.

You will be trained in the following areas:

Competency in ISO 13485:2016

• Understanding concept of ISO 13485:2016 standard and the impact of the requirements on lab operations.
• Management of Change.
• Management of deviation and nonconformity.
• CAPA and root cause analysis.

Workplace Safety, Health and Environment

• Application of safe work procedures in work activities.
• Workplace safety incident investigation.
• Proper classification, handling, storage and disposal of lab chemicals including toxic, corrosive, flammable chemicals.
• Proper handling, storage and disposal of biological materials.
• Emergency response.

Facility Management

• Regulatory requirement for lab operations.
• Regulatory guideline for waste management.

Equipment Maintenance

• Understand the purpose of equipment calibration.
• Understand concept of accuracy and tolerance in calibration results.

Equipment Qualification

• Understand the principles of equipment qualification.
• Writing qualification protocol and report.
• Execute basic installation and operations qualification protocols.

You will support the QA and lab operations team in the following:

• Receiving and inspection of material and equipment.
• Equipment qualification: develop qualification protocol/report, plan for qualification activities.
• Support in maintenance of lab facility compliant to ISO 13485 and regulatory requirement.
• Review/drafting of SOP.
• Participate in audit.
• Record NCR and conduct CAPA process.
• Participate in lab improvement project.
• Cross division activities on adhoc basis.

Job Requirements

• Bachelor of Science or Engineering with knowledge in engineering science.
• Working knowledge in Microsoft office.
• Good communication and presentation skill.
• Individual who is highly motivated, results driven and well organized.
• Possess intellectual agility and a strong team player.
• Applicants with no experience may apply.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.