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Qc Engineer
2 weeks ago
Responsibilities:
- Working with Process Engineer & Engineering team on QC requirement
- Documenting inspection criteria and quality plan
- Work with QA, Process and Product team on corrective action with quality issue
- Work with Process team on in-process audit and FQC audit
**Requirements**:
- Minimum Diploma in Manufacturing /Quality Engineering
- At least 1 year of relevant working experience in Electronics Product Manufacturing environment
- Control of Supplier Quality Assurance (SQA)
- Quality control of in-coming, in-process and out-going products
- Knowledge of ISO 9001, 14001, 13485 & 45001, FDA requirement
- Able to understand IPC requirement in PCB Assembly, quality requirement of plastic molding, die casting, extrusion, metal stamping and machining parts
- Able to converse with the China suppliersResponsibilities:
- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap
- Manage and oversee quality audits by plan and ensure quality audits findings and recommendations are rectified and implemented. Apprise management of quality audit findings and corrective actions taken
- Ensure that the procedures and processes prescribed by the Quality Management System are in place and implemented per requirement
- Review the Quality Management System periodically to assess continued suitability and areas of possible improvement
- Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and further refresher training as needed
- Co-ordinate and plan work of external audit such as Customer, ISO certification and Regulatory bodies
- Ensure that systems and procedures are in compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements
- Mentor / supervise as assigned and ensure timely and accurate completion of quality projects
- Support Plant wide audit/ inspection activities and special projects, as assigned
- Able to travel for suppliers / customer visits
**Requirements**:
- Bachelor’s Degree in Quality Management or Engineering
- At least 3 years of working experience in Quality Management System, and in manufacturing environment
- Excellent hands on knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820
- Lead, mentor and facilitate problem solving and quality improvements
- Establish controls system required in ISO13485 & FDA registered facility
- Strong communication and interpersonal skills
- FDA Inspection experience preferredResponsibilities:
- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap
- Manage and oversee quality audits by plan and ensure quality audits findings and recommendations are rectified and implemented. Apprise management of quality audit findings and corrective actions taken
- Ensure that the procedures and processes prescribed by the Quality Management System are in place and implemented per requirement
- Review the Quality Management System periodically to assess continued suitability and areas of possible improvement
- Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and further refresher training as needed
- Co-ordinate and plan work of external audit such as Customer, ISO certification and Regulatory bodies
- Ensure that systems and procedures are in compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements
- Mentor / supervise as assigned and ensure timely and accurate completion of quality projects
- Support Plant wide audit/ inspection activities and special projects, as assigned
- Able to travel for suppliers / customer visits
**Requirements**:
- Bachelor’s Degree in Quality Management or Engineering
- At least 3 years of working experience in Quality Management System, and in manufacturing environment
- Excellent hands on knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820
- Lead, mentor and facilitate problem solving and quality improvements
- Establish controls system required in ISO13485 & FDA registered facility
- Strong communication and interpersonal skills
- FDA Inspection experience preferredResponsibilities:
- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap
- Manage and oversee quality audits by plan and ensure quality audits findi