QA Manager

3 days ago


Singapore People Profilers Full time

Job Description:

- **Title : QA Manager**:

- ** Industry : Manufacturing**:

- ** Location : East**:

- ** Working Hours : 9am to 6pm**:

- **Salary Range : Up to S$6,500 Per month 
**Responsibilities**:

- To formulate, implement and review work procedures to ensure effectiveness and efficiency to meet quality and regulatory requirements.
- To ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirements in all assigned areas.
- To support the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.
- To ensure overall compliance adequacy and operational effectiveness of the QA Operations (QA incoming, in-process QA and DHR management) for the contact lens and lens care products manufacturing.
- To work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield. Leading and participating in quality improvement programs and cross functional projects.
- To conduct / coordinate failure analysis for customer complaint returns. To manage customers complaint by coordinating with internal and external departments and submission of QA CAR to customers.
- To coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.
- To ensure that the Quality and company objectives set by Managing Director and/or Chairman are achieved, and that the business activities have the correct organization and people to achieve maximum performance in the short and continuing long term.
- To develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, MDR Certification, CE Certification, MOH Certification and other GMP systems.
- To promote awareness, implement and enforce the companys QMS and regulatory requirements for the improvement of current processes, controls and quality systems.
- To review, update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides.
- To ensure that gap analysis is performed on deficiencies caused by the updating of versions/editions of Standards, Guidance and Technical Guides.
- To act as QMR with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.

**Requirements**:

- Degree in Engineering, Life Sciences or equivalent.
- ISO 13485:2016 lead auditor
- At least 3 years quality management related experience in medical device industry with minimum 2 years experience in regulatory affairs.
- Lead auditor in ISO 13485:2016 system
- Experience in the Application of Risk Management (ISO 14971:2019), FMEA and Application of Usability Engineering (EN 62366-1:2015).
- Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.
- Knowledgeable in Validation/Qualification process.
- Team player with good and positive working attitude.
- Effective in decision making capabilities.

Job ID: QY5YRY99

People Profilers Pte Ltd, 20 Cecil Street, #08-09, PLUS Building, Singapore 049705.
Tel: 6950 9740 / 9640 5305

EA License Number: 02C4944
Registration Number: R1330005
Posting Personnel: Reeve Lim Kok Kiong


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