Manufacturing Quality Engineer
Manufacturing Quality Engineer
Randstad Singapore- Posted 18 days ago
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Job Description
about the company
My client is a specialized manufacturer in the contract manufacturing space. They are a Singapore based company and with their innovative technology, this is a great brand to join at an exciting time in their development.
about the job
- Plan, coordinate and oversee all Quality Assurance activities in the Company
- Oversee the Documentation Control function for Quality Management System
- Act as the Quality Management Representative for the Company
- Develop and implement plans to collect quality data at in-process, final inspection, test and inspection stations
- Plan and execute annual Internal Audit to ensure all quality systems and procedures are effectively implemented and auditable at all times
- Manage first article inspections and sample evaluation activities
- Partner with engineering and local suppliers to address quality issues at the source. Support design transfers, process validations (IQ/OQ/PQ), and perform PFMEAs for new projects
- Oversee incoming, in-process, and final End-Of-Line (EOL) testing and inspections
- Manage first article inspections (FAI), maintain Device History Records (DHR), and perform final quality sign-off for product release
job requirement
- Bachelor's Degree / Diploma in Mechanical Engineering
- 3+ years of Quality Engineering experience in a high-volume plastics injection or regulated medical device manufacturing environment
- High volume manufacturing environment
- Deep understanding of ISO 13485 and FDA 21 CFR Part 820
- Proven experience writing and executing NCRs, CAPAs, deviation reports, and process validations (IQ/OQ/PQ)
- Proficiency in reading engineering drawings/GD&T and using measurement/inspection tools
If you are interested in the position
Please include your availability, expected salary and reason for leaving current job
We regret that only shortlisted candidates will be contacted
EA: 94C3609 / Reg: R1325913
More Info
Key Skills
IQ OQ PQ
PFMEAs
Device History Records
First Article Inspections
Design Transfers
Sample Evaluation
NCRs
Documentation Control
Deviation Reports
Process Validations
Measurement Inspection Tools
Reading Engineering Drawings
About Company
Skills:
Statistical Analysis, Iso 13485, Lean, Fmea, Spc, Gmp, 5 Whys, Capa, manufacturing quality tools, Kaizen, Process Validation, FDA QMSR, Fishbone, IQ OQ PQ validation, Msa, Iso 14971
Skills:
Corrective and Preventive Actions (CAPA), Material Review Board (MRB), Potential Failure Mode Effect Analysis (PFMEA), Forms, 5W problem solving methodology, Supplier on-boarding, work instructions, Control Plans, Quality Manual, Procedures, SCAR system, Iso 9001, Supplier Management, Internal and external audits, Supplier quality agreement, ISO 22301
Skills:
quality assurance, Iso 9001, Fmea, Quality Control, Spc, Root Cause Analysis, Capa, quality management systems
Skills:
Inspection Test Plans, Corrective and preventive action programs, Quality Assurance Plans, Spc, ISO9001 2015 accredited certification, ISO 9000 series Quality system, 5S, PFMECA
Skills:
Quality Assurance, Statistical Analysis, Quality Management Systems, Root Cause Analysis, Fmea, Quality Engineering Methodologies, Spc, Process Improvement, Supplier Quality Management, 8D, Capa, Iso 9001