Senior Quality & Validation Engineer SE}

ARCH•Bartlett, TN

About The Position

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 addresses customer quality inquiries and issues, supports production and manufacturing engineering personnel, and helps ensure customer requirements and activities are handled in accordance with the Quality Management System. It also involves developing quality plans and documentation, supporting inspections and corrective actions, and implementing verification technologies and quality software as applicable. The position requires broad knowledge of FDA Quality System Regulations and ISO 13485, proficiency with measurement and inspection methods, and the ability to analyze and communicate technical information. The employee may be asked to perform other job-related duties and cross-functional tasks as needed. ARCH Global Precision describes itself as an Equal Opportunity Employee and states that employees are employed on an at-will basis.

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 express 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.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; respond to common inquiries or complaints; write speeches and articles in prescribed formats; and present information effectively to management, public groups, and boards of directors.
Ability to solve practical problems involving concrete variables and limited standardization, and interpret written, oral, diagrammatic, or scheduled instructions.
Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
Ability to occasionally stand, walk, and sit; ability to adjust focus; and ability to lift or carry up to 30 pounds.

Nice To Haves

Bachelor’s degree or equivalent; previous experience preferred.

Responsibilities

Respond to customer quality inquiries and provide technical assistance; determine and implement appropriate dispositions for customer issues.
Provide technical assistance and training to production and manufacturing engineering personnel.
Participate in contract review to ensure Engineering Master documentation addresses customer requirements 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 action, 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 if 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.
Perform other job-related duties as assigned.