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QA Manager

2 weeks ago

Singapore SKANDA TECHNOLOGIES PTE. LTD. Full time

**_Responsibilities: _**:
QA Manager (with QMR Functions)
- 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 correcl 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, CE Certification, MOH Certification

and other GMP systems.
- To promote awareness. implement and enforce the company's QMS

and regulatory requirements for the improvement of current

processes, controls and quality systems.
- To review, update and maintain the National and International

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.

**_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.
- Familiar with cGMP and EU MDR 2017/745 requirements.
- Trained 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).
- Understanding of ISO 13485:2016, EU MDR 2017/745, US FDA QSR,

MDSAP and MY-MDA requirements.
- Understanding of quality control/assurance methodology and
- Working knowledge of metrology tools and equipment such as

calipers, micrometers and lensmeter.
- Knowledgeable in Validation/Qualification process.
- Able to adapt in a fast-paced environment with minimum guidance.
- Possess strong leadership, positive attitude and good interpersonal

skills.
- Strong technical writing skills.
- Team player with good and positive working attitude.
- Effective in decision making capabilities.
- Meticulous in preparing reports, protocols and other documentation