Clerk, Document Control

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Quasar Medical (Singapore) pte.ltd. is seeking a Quality Supervisor to oversee QA documentation and control activities within our Singapore operations, ensuring compliance with QMS and regulatory requirements.

You will lead document control, support NPIs, collaborate with engineering, and drive improvements to records, test reports, and change management while maintaining traceability in a cleanroom environment.

Qualifications

• Maintains quality records and systems per regulatory requirements.
• Develops, enhances and revises documentation procedures and archiving.
• Train relevant personnel on documentation standards and practices.
• Supports internal and external quality system audits.

Responsibilities

• Lead document control to ensure traceability and integrity of records.
• Collaborate with Quality System Engineer on QMS duties.
• Oversee release of documents for NPI to meet requirements.
• Maintain Design History Files and validation/test reports.
• Assist in NC, CAPA, SCAR, and change control processes.

Skills

Communication

MS Office proficient

Quality mindset

Education

GCE O Level or higher

Diploma in technical field (preferred)

Tools

CAD software drawing

Database administration

Electronic filing

Job description

Our Culture We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

Job Summary:

• The Quality Supervisor is responsible for the supervisor of the Quality Control activities within Quasar Singapore Operations and is responsible to ensure that the duties of the Quality Technicians under him/her are properly discharged, effectively and efficiently.

Essential Duties and Responsibilities:

• Work closely with Quality System Engineer in his/her discharge of his/her Quality System duties.
• Lead in the released of documents for the NPI-New Product Introduction to ensure it meets the QMS requirements.
• Works with the Engineering and Project team in the final hand over of controlled document deliverables.
• Ensure that documentation and records that relate to the requirements of the Quality System are controlled in a manner, which ensures traceability, integrity and accessibility.
• Develop, enhance and revise documentation procedures, implements necessary updates, and maintains all required documents as defined by applicable regulations.
• Train relevant personnel on documentation standards and practices.
• Assist relevant personnel in the creation of Change Plan (CP) / Engineering Change Order (ECO) packets for compliance with established requirements. Reviews all such packets, resolves issues with the initiator of the change, and enters the document into the Document Control System.
• Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents and promptly removes any obsolete documents from all points of issue or use.
• Communicate and promote awareness of document control systems, processes and standards where required
• Monitor of log sheets management for CP/ECO, SCAR, NC, DA, CAPA, complaints, RMA, etc
• Maintain validation reports, test reports, records, Design History Files, etc. as defined by applicable regulations and standards.
• Assist and monitor weekly meeting of NC and CAPA
• Assist in all external customer and quality system audits.
• Assist in internal auditing of the Quality System.
• Assist in management of SCAR, NC, DA, CAPA, complaints and RMA programs.
• Able to work independently to perform multiple tasks in the document control area.

Authority:

Education/Experience and Qualifications:

• GCE "O" Level or higher; Diploma preferred in a technical field or equivalent, with 3-5 years of progressive in-depth experience in maintaining quality records and quality systems, preferably in Medical Device Manufacturing.
• Experience in developing, enhancing, implementing, and maintaining a documentation system that demonstrates compliance with applicable regulatory requirements, or similar document creation, filing, and/or archiving.
• Excellent Communication Skills.
• Proficiency in Microsoft Word, Excel, and Power Point. Preferably has experience with electronic filing, database administration and/or CAD software drawing.
• Ability to perform activities to support product development, manufacturing, and release as identified by Senior Management;
• Knowledgeable in writing manufacturing procedures and GMP requirements
• Knowledge of ISO 9001, ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directive.

Work Environment:

• While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
• Controlled Environment (Class 10K/100K cleanroom) and office area.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority - it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously. Explore exciting career opportunities with Quasar by browsing our current job openings.

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives.