Senior Quality & Validation Engineer {SE}

ARCH; Memphis (TN); On-site; USD 85,000 - 120,000; Full time

Job summary

ARCH Medical Solutions in Bartlett, TN is seeking a Senior Quality & Validation Engineer to lead the engineering aspects of the quality function. You will handle customer inquiries, provide technical assistance, and train production teams while ensuring compliance with QA systems.

The role includes defining inspection methods, participating in CAPA, and supporting receiving and in-process inspections for new products. Strong expertise in CMM, ISO 13485, and FDA QSR is essential.

Qualifications

• Broad knowledge of FDA Quality System Regulations and ISO 13485.
• Proficient with CMM, surface plate technology, shop math, and inspection instruments.
• Strong analytical skills and the ability to express technical concepts clearly.
• Proficient at data collection, analysis, and presentation.
• Excellent computer skills with MS Office.
• Strong communication skills to work with customers.

Responsibilities

• Responsible for all engineering aspects of the quality function.
• Responds to customer quality inquiries and provides technical assistance.
• Provides training to production and manufacturing engineering personnel.
• Participates in the Contract Review process to address customer requirements.
• Prepares quality control plans and IMS sheets.
• Defines inspection methods and selecting gauges for inspections.
• Participates in corrective actions including RCA, CAPA.
• Assists with receiving, in-process, and final inspections for new products.
• Ensures activities comply with the Quality Management System.
• Creates and maintains quality system documentation.
• Recommends and implements new part verification technologies.
• Understands and implements advanced Quality Software; CMM and Vision System Programming.

Skills

Quality engineering

CMM

Blueprints

Data analysis

Communication

MS Office

Education

Bachelor degree

Tools

CMM software

Vision system

Inspection gauges

Job description

Senior Quality & Validation Engineer {SE}

Job Category: Engineering

Requisition Number: QUALI005394

• Full-Time

Locations

Showing 1 location

ARCH Medical Solutions - Memphis
7580 Bartlett Corporate Dr
Bartlett, TN 38133, USA

Description

Provides statistical information for quality improvement by identifying testing methods and samples. Responsible for all engineering aspects of the company quality function.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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.li>
• 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.

Qualifications

• Broad knowledge of FDA Quality System Regulations and ISO 13485 standard.
• 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.

Education and/or Experience

• Bachelor degree or equivalent, previous experience preferred

Language Skills

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

• Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus. Lifting/carrying up to 30lbs.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

ADDITIONAL NOTES

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.