336 Senior Quality Engineer Jobs in Irvine, CA
Fong’s Engineering and Manufacturing Pte Ltd is Hiring a Senior Quality Engineer Near Irvine, CA
The Role
- Acting as the Quality Leader, he/she will report directly to Singapore HQ for all Quality matters for Irvine Service Centre (ISC).
- Ensures ISC complies with all relevant local, state and federal regulations and obtains necessary certifications and approvals from regulatory bodies including FDA and ISO
- Develop and implement a robust QMS for ISC by working closely with Singapore HQ
- Prepares plan for GxP software implementation together with Service Operations team for proposal to top management.
- Strategize and develop a sustainable model for execution of quality event reporting for internal and external stakeholders.
- Works closely with Service Operations, Customer Service team to co-develop an efficient process flow for servicing medical equipment returns.
- Handles customer complaints, investigations
- Lead and drive all validation activities during the setup phase of the ISC
- Establish, develop and document Quality SOPs and WI for all service center operations.
- Leads and prepare Irvine team for internal and external audits
- Oversees daily tasks related to Quality operations
- Perform other ad-hoc duties as assigned by immediate supervisor.
- Degree in Engineer or related field
- Passion for detail with strong drive to complete tasks timely and efficiently
- Strong working knowledge of ISO 13485 and FDA QSR.
- Strong working knowledge of Verification and Validation concepts
- Qualified Lead Internal Auditor experience will be a strong advantage
- Demonstrate strong understanding of QMS setting up and maintenance processes.
- Candidates with good qualifications and experience may be considered for a more senior role
- Fantastic work culture
- A role that offers a breadth of learning opportunities
- Work alongside & learn from best in class talent
Job Summary
Full Time
$87k-104k (estimate)
07/04/2024
08/01/2024
The job skills required for Senior Quality Engineer include ISO, Customer Service, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Quality Engineer positions, which can be used as a reference in future career path planning. As a Senior Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Quality Engineer. You can explore the career advancement for a Senior Quality Engineer below and select your interested title to get hiring information.
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