East Jobs Qa Manager (iso13485, Mdd/mdr) Sx55 Position at TRUST RECRUIT PTE. LTD.
- Job vacancies posted on: 9 months ago
We are currently looking for adequate candidates to fill the position of QA Manager (ISO13485, MDD/MDR) SX55. For candidates who reside in East and its surrounding areas, we are looking forward to hearing from you to join our team at TRUST RECRUIT PTE. LTD. and willing to work in our office under full time working hours system.
We have specific requirements for each of our employees as well as potential workers because we are a professional and knowledgeable business in the field we work in. We look forward to hearing from you soon if you have expertise in the fields of Manufacturing & Quality Assurance with a minimum Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree & Master's Degree.
We can give you a fairly competitive salary in the amount of SGD 5.000 - SGD 7.000 on average. It also can be modified based on the credibility and experience you can provide for our business in accordance with our company HRD agreement.
|TRUST RECRUIT PTE. LTD.
|Qa Manager (iso13485, Mdd/mdr) Sx55
|Advanced/Higher/Graduate Diploma, Bachelor's Degree, Diploma, Master's Degree, Post Graduate Diploma, Professional Degree
|Type of Work
- 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.
- Preferred with Diploma & Degree in Engineering, Life Sciences or equivalent.
- ISO 13485:2016 lead auditor
- At least 2 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.
- Able to adapt in a fast-paced environment with minimum guidance.
HOW TO APPLY:
Interested applicants, kindly send your resume in MS WORD format, or drop a WS (8900 6399) for faster shortlisting, please click on “Apply Now” and provide the below details in your resume.
1. Reasons for leaving ALL your employment
2. Current and/or last drawn monthly salary (please provide breakdown)
3. Expected monthly salary
We regret only shortlisted candidates will be notified.
Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA). Please read our privacy statement on our corporate website ww.trustrecruit.com.sg.
Trust Recruit Pte Ltd
EA License No: 19C9950
EA Personnel: Lee Shong Xian (Leo)
EA Personnel Reg No: R22104917
- Get work experience
- Bonus for overtime
- Be taught first
- Good work environment
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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.
- Industry: Human Resources Management / Consulting
- Registration No.: 201935022Z
- EA No.: 19C9950
- Company Size: 1 - 50 Employees
- Average Processing Time: 5 days
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