Senior Quality & Validation Engineer SE}
About The Position
The Senior Quality & Validation Engineer provides statistical information for quality improvement by identifying testing methods and samples and is responsible for engineering aspects of the company quality function. The role responds to customer quality inquiries, provides technical assistance, and determines and implements appropriate dispositions. It also supports production and manufacturing engineering personnel through technical assistance and training. The position participates in contract review to ensure engineering masters address customer requirements; prepares quality control plans and IMS sheets; defines inspection methods and selects gauges; and contributes to corrective and preventive action activities. The engineer supports inspections for new products, maintains quality system documentation, and ensures assigned work follows the Quality Management System. The role may recommend and help implement part-verification technologies, use advanced quality software, program CMM and vision systems, and perform cross-functional tasks as needed.
Requirements
- Broad knowledge of FDA Quality System Regulations and the ISO 13485 standard.
- Proficiency with CMM, surface plate technology, shop math, mechanical inspection instruments, and blueprints.
- Strong analytical skills and ability to communicate technical concepts effectively in writing and verbally.
- Proficiency in data collection, analysis, and presentation.
- Excellent computer skills, including proficiency with Microsoft Office and the internet.
- Strong communication skills and ability to work closely with internal and external customers.
- Bachelor's degree or equivalent.
- Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
- Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to write speeches and articles for publication and present information effectively to management, public groups, and boards of directors.
- Ability to solve practical problems and interpret written, oral, diagrammatic, or scheduled instructions.
- Ability to use Microsoft Office applications, including Word, Excel, and Outlook.
- Ability to occasionally stand, walk, and sit, adjust focus, and lift or carry up to 30 pounds.
Nice To Haves
- Previous experience is preferred.
Responsibilities
- Provide engineering support for the company quality function.
- Respond to customer quality inquiries and provide technical assistance and appropriate dispositions.
- Provide technical assistance and training to production and manufacturing engineering personnel.
- Participate in contract review to ensure engineering masters address customer requirements documented in supplier agreements, procedures, work instructions, and engineering drawings.
- Prepare quality control plans and IMS sheets.
- Define inspection methods and select gauges for inspection activities.
- Participate in corrective action activities, including investigation, root cause analysis, corrective actions, and preventive actions.
- Assist with receiving, first-piece, in-process, and final inspections for new products as required.
- Ensure assigned activities are performed in accordance with the Quality Management System.
- Create and maintain quality system documentation.
- Recommend new part-verification technologies and assist with implementation when approved.
- Understand and implement advanced quality software as applicable.
- Program CMM and vision systems.
- Perform cross-functional tasks as required until appropriate resources are in place.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
