Job Description

Position title : QA Manager (with QMR and PRRC Functions)

Location: Joo Seng Road (near Tai Seng MRT)

Working Days: Monday - Friday

Working hours : 9am -6pm

Salary : $5,000 - $6500 (depends on qualifications and experiences)



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, 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 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 and PRRC 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.
• 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 Sampling Plan by Attributes and its applications.
• Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.
• Knowledgeable in Validation/Qualification process.
• Proficient in Minitab and MS Office applications.

Interested Personal kindly contact WhatApps :+65 8833 7969(Lydia)

Lydia Chieng Zhi Yee Reg No: R1988890

The Supreme HR Advisory Pte Ltd EA No: 14C7279

Additional Information

Career Level

Senior Executive

Qualification

Diploma, Advanced/Higher/Graduate Diploma, Bachelor\'s Degree, Post Graduate Diploma, Professional Degree

Years of Experience

3 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Here at The Supreme HR Advisory, we pride ourselves on being a vibrant recruitment firm with strong Southeast Asia standing. We believe in customizing our services to your unique needs. We are dedicated, enthusiastic and we take innovative approaches in customizing our services. Our depth of experience enables us to understand each industry\'s challenges and provide expert advice on hiring requirements. Our goal is to leverage on our local knowledge and global expertise to deliver high-quality candidates specifically matched to the requirements of each of our client.

Additional Company Information

Registration No.

201426535W

EA No.

14C7279

Company Size

51 - 200 Employees

Average Processing Time

12 days

Industry

Human Resources Management / Consulting

The Supreme HR Advisory