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Assistant/Quality Assurance Manager (MNC/ISO 13485/5 days) Singapore

CVISTA HR CONSULTING PTE. LTD.

CVISTA HR CONSULTING PTE. LTD. Singapore Singapore

2 weeks ago

Additional information:
• 5 days, West, Transport provided
• $6000 - $7000, AWS, performance bonus
• Able to start within short notice
• ISO 13485 certified

Responsibilities:
• Support on all Integrated Management System (IMS) relevant activities, with reference to ISO 9001, ISO 14001, ISO 13485 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.

Interested applicants, please send your resume to [email protected]

MOM License 16C7883 | Reg No. R1109186
Singapore

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