What a typical day looks like:
- Participate actively on transferring of new projects from new customer and supporting to set up the NPI product line
- Interface with production , process and test engineering to ensure that products are consistently produced and controlled as per Good Manufacturing Practice (GMP)
- Establish and maintain Quality Control Plan , Risk Management Plan & Report, Device Master Record, FQA Critical component checking plan of the product
- Interface with customers on technical and quality issues and improvement initiatives and provide failure analysis and corrective action reports upon customers request
- Responsible for managing customer audits and regulatory and compliance agency audits
- Responsible for authorizing the released of final products to customer and training to FQA personnel and Product Quality Engineering Assistant
- Ensure that the manufactured and shipped products are in compliance with international industrial standards and customer requirements
- Follow up on quality issues identified to ensure corrective actions are in place and effective.
- Work closely with planner, PA, test and process engineers to effectively support for daily manufacturing activities and improve yield
- Participate in internal and external audits of QMS
- Participate in MRB (Material Review Board) review process to make sure timely turnaround of nonconformance material disposition, rework and closure
- Provide factory support to identify and resolve issues associated with purchased parts , materials and manufacturing
- Other relevant duties as assigned
The experience we're looking to add to the team:
- Diploma/Degree in Mechanical Engineering/Electrical Electronics Engineering/Manufacturing Process Technology
- At least 5 years of manufacturing experience in similar role
- Familiarity in ISO 13485 Quality System Requirements and FDA CFR Part 820 regulations will be an added advantage
- Able to interpret within established procedures and practices as well as exercise independent judgment in complex situations
What you'll receive for the great work you provide:
- Medical benefits
- Life Insurance
- Paid Time Off
- Allowances and Bonuses
