Assistant/qa Manager
2 weeks ago
5 days, West, Transport provided
- $7500 - $8000, AWS, performance bonus, allowances
- Able to travel to U.S
- Estimated dates for travel (Jul 23 -Sep 23 & Nov 23 - Dec 23)
- **ISO 13485 certified (must have)**
**Responsibilities**:
- Support on all Integrated Management System (IMS) relevant activities, with reference to ISO 9001, ISO 14001, ISO13485 and SS620 standards requirement.
- Assess the quality management arrangement for subcontracting & purchasing activities.
- Provide management information on quality management.
- Overall reviewer to ensure completeness & compliance of site’s IMS / QMS / EMS activities, documentation & processes.
- Plan & handle internal & external (certification & customer) audits relevant to the site.
- Identify deficiencies, resolve problems & implement solutions affecting the IMS / QMS.
- Support other delegated IMS or project tasks.
- For ISO 13485, perform medical device file & medical device product release review.
- Initiate & manage the timely completeness of customer complaints, actions implementation, effectiveness review & report completion.
- To execute Vendor Performance Assessment Program.
- Ensure & verify timely corrective action is performed.
**Requirements**:
- Possess a Degree in Engineering, Biomedical Science or Science related discipline
- **ISO 9001, 14001 & 13485 trained.**:
- 3 to 5 years of relevant certification system experience
- Willing to take on any new work assigned by higher management.
- Able to work independently in a fast-paced environment.
- Good knowledge in RoHS & regulatory requirements.
- Good PC (MS Word, Excel & PowerPoint) & analytical skills.
- Added advantage with Lean Six Sigma, 6S & Kaizen experience.
MOM License 16C7883 | Reg No. R1109186
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