Senior Quality & Validation Engineer - Impact & Compliance

ARCH Medical Solutions; Bartlett (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

ARCH Medical Solutions in Bartlett, TN seeks a Senior Quality & Validation Engineer to lead quality systems, validation activities, and supplier interfaces. You will define inspection methods, coordinate CAPA, and drive continuous improvement in product quality.

The role requires a Bachelor's degree, proficiency with CMM and measurement tools, strong data analysis and communication skills, and knowledge of FDA QSR and ISO 13485.

Qualifications

• Broad knowledge of FDA Quality System Regulations and ISO 13485.
• Proficient with CMM, surface plate technology, shop math, and mechanical inspection instruments, and blueprints.
• Strong analytical skills and the ability to express technical concepts effectively, both written and verbal.
• Proficient at data collection, analysis, and presentation.
• Excellent computer skills and proficiency with MS Office and the internet.
• Strong communication skills and ability to work closely with external and internal customers.

Responsibilities

• Responsible for all engineering aspects of the company quality function.
• Receives customer contacts by telephone, fax, letters, and in person. Responds to all customers' quality inquires; provides technical assistance to customer's issues, and determines and implements appropriate disposition.
• Provides technical assistance and training to production and manufacturing engineering personnel.
• Participate in Contract Review process to assure that Engineering Master addresses all customer requirements as documented in supplier agreements, procedures, work instructions, and engineering drawings.
• Prepares quality control plans and IMS sheets
• Defines inspection methods and selecting gauges appropriate for inspection activities.
• Participates in corrective action 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.
• Responsible for assuring that assigned activities are performed in accordance with Quality Management System.
• Responsible for creating and maintaining quality system documentation.
• Recommend new part verification technologies and if approved, assist in implementation
• As applicable, understand and implement advanced Quality Software.
• CMM and Vision System Programming
• As required, perform cross functional task until appropriate resources are in place.

Skills

FDA QSR

ISO 13485

Analytical skills

Data presentation

Communication

MS Office proficiency

Education

Bachelor's degree

Tools

CMM

Vision System

MS Office

Job description

ARCH Medical Solutions in Bartlett, TN seeks a Senior Quality & Validation Engineer to lead quality systems, validation activities, and supplier interfaces. You will define inspection methods, coordinate CAPA, and drive continuous improvement in product quality.

The role requires a Bachelor's degree, proficiency with CMM and measurement tools, strong data analysis and communication skills, and knowledge of FDA QSR and ISO 13485.