Job Description

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 I 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 OMS 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.

Requirements:

• Only Singaporean
• 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 lens meter.
• 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.
• Proficient in Minitab and MS Office applications.
• Strong technical writing skills.
• Team player with good and positive working attitude.
• Effective in decision making capabilities.
• Good eyesight
• Meticulous in preparing reports, protocols and other documentation.

Information:

• Salary: up to $7,000 + VB
• Location: Joo Seng Rd (Nearest MRT Tai Seng)
• Working hours: Monday - Friday, 9am - 6pm

HOW TO APPLY:

Interested applicants, kindly send your resume in MS WORD format to ref25(at)trustrecruit.com.sg or please click on \xe2\x80\x9cApply Now\xe2\x80\x9d and provide the below details in your resume. * Reasons for leaving ALL your employment

• Current and/or last drawn monthly salary (please provide breakdown)
• Expected monthly salary
• Availability

We regret only shortlisted candidates will be notified.

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Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Foong Mei Qi

EA Personnel Reg No: R22106936

Additional Information

Career Level

Manager

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Trust Recruit is Singapore\'s leading relationship-based human resource and recruitment firm. With more than 20 years of collective consulting experience, we provide personalized workforce solutions for our corporate clients, ranging from multinational corporations to the public sector, as well as small and medium enterprises.

At Trust Recruit, integrity and reliability permeates every level of our recruitment process. TRUST is our currency of interactions; be it with our valued clients, talented job-seekers or our own employees. Through our premium staffing services, we are committed to connecting and developing quality relationships between candidates and companies.

Additional Company Information

Registration No.

201935022Z

EA No.

19C9950

Company Size

1 - 50 Employees

Average Processing Time

6 days

Industry

Human Resources Management / Consulting

Specific Location

Joo Koon

Trust Recruit