Kerja Sepenuh Masa, QA Engineer (QMS)- Document Control di Vital Healthcare Selangor - Maukerja

About the role

Vital Healthcare Sdn Bhd is seeking a QA Engineer (QMS) and a Document Control Executive professional to join our team in Klang, Selangor. These positions are responsible for maintaining and improving the Company's Quality Management Systems in compliance with the ISO13485 and other related regulatory requirements.

Key responsibilities - QA Engineer (QMS)

1. Review and approve batch records before submission to the Document Control Center.

2. Maintain and revise departmental quality documents and SOPs.

3. Conduct self-inspections and internal audits to ensure compliance with quality management system requirements.

4. Track and verify the effectiveness of corrective actions arising from audit findings and non-conformities.

5. Support and accompany external auditors during regulatory, customer, and certification audits.

6. Prepare CAPA reports and monitor implementation progress.

7. Coordinate and manage employee training programs and training records.

8. Perform routine audits and spot checks of workshop records and batch documentation.

9. Manage engineering change control processes from initiation through closure.

10. Continuously improve departmental quality systems and oversee compliance with quality procedures and requirements.

11. Perform any other duties assigned by the superior.

Key responsibilities - Document Control Executive

1. Establish, maintain, and administer the document control system to ensure all controlled documents are properly reviewed, approved, issued, distributed, and archived.

2. Manage document numbering, version control, revision history, and document status to ensure only current and approved documents are available for use.

3. Coordinate the issuance, distribution, collection, and withdrawal of controlled documents, including SOPs, work instructions, forms, specifications, and quality manuals.

4. Review submitted documents for completeness, formatting compliance, and approval requirements before release.

5. Maintain and update the master document list and ensure document records are accurate and up to date.

6. Manage the storage, retention, retrieval, and disposal of quality records in accordance with company procedures and regulatory requirements.

7. Perform filing, indexing, scanning, and archiving of documents and records to ensure traceability and accessibility.

8. Conduct periodic reviews of document control activities to ensure compliance with applicable quality management system requirements.

9. Support departments in document preparation, revision, and submission processes while ensuring adherence to document control procedures.

10. Prepare and provide required documentation and records during internal audits, external audits, customer audits, and regulatory inspections.

11. Perform any other duties assigned by the superior.

What we're looking for

1. Bachelor's Degree in Quality Management, Engineering, Manufacturing, Industrial Management, or related discipline.

2. Familiarity with related ISO standard and/or GMP requirements

3. Experience in document review, document control, or quality management systems (QMS) will be an added advantage

4. Prior experience in the medical device industry is preferred.

5. Good communication, coordination, and interpersonal skills.

6. Detail-oriented, well-organized, and able to uphold quality and compliance standards.

7. Knowledge of CAPA and NCR processes.

8. Experience participating in external & internal audits.

9. Workshop management or on-site operational experience is an advantage.

What we offer

At Vital Healthcare Sdn Bhd, we are committed to providing a rewarding and supportive work environment for our employees. You can expect:

• Competitive salary and benefits package

• Opportunities for professional development and career advancement

• Comprehensive training and mentorship programs

• Access to employee wellness and recreational activities

Other Benefits

• On-the-job training will be provided

• Medical Benefits

• Incentive Allowance

• Seniority Reward

• Year-end salary adjustment

• Year-End Bonus

About us

Vital Healthcare Sdn Bhd is a leading manufacturer of high-quality medical devices and pharmaceutical products. Our mission is to improve the health and well-being of our communities by delivering innovative and reliable healthcare solutions. With a strong track record of quality and excellence, we are committed to maintaining the highest standards in our industry.

If you are passionate about quality assurance and driven to make a meaningful impact, we encourage you to apply for this exciting opportunity. Apply now to join our team at Vital Healthcare Sdn Bhd.