Quality Engineer

Quality Engineer

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

• Manage quality assurance processes for multiple customers with varying requirements
• Interface directly with customers to address quality issues
• Perform root cause analysis and lead corrective and preventive action activities (CAPA)
• Oversee data driven process improvement projects
• Document and maintain control of SOPs, forms, and other QMS items
• Assist with internal and external quality audits
• Oversee validation activities for entire organization
• Monitor quality metrics & drive improvement initiatives
• Prepare and maintain quality documentation such as process flows, PFMEA's, control plans, gage R & R's, FAI reports, and inspection sheets
• Collaborate with production, engineering, and supply chain teams to ensure quality standards are met throughout the production lifecycle, resolve quality issues, enforce standards, and drive continuous improvement initiatives
• Assist with Material Review Board (MRB) activities by documenting and investigating nonconformances
• Review customer facing quality records and Certificates of Compliance
• Oversee and support supplier quality controls and feedback

Education and/or Experience

• STEM Degree at Bachelor level or above or equivalent experience/combined education
• Minimum 5 years of experience in a manufacturing environment with a focus on quality

Job Knowledge, Skills and Abilities

• Strong knowledge of ISO 13485, GMP, and/or ISO 9001 standards
• Advanced understanding and knowledge of dimensional inspection methods, GD&T, and precision measurement tools (micrometers, calipers, height gages, comparator, scope, CMM, etc.).
• Demonstrated ability to use causal analysis tools (5 Whys, Fishbone, 8D, Pareto) as well as statistical techniques (SPC, capability analysis) to analyze and resolve technical/process issues
• Proficiency in Microsoft Office and experience with ERP or quality management software preferred.
• Strong communication skills and ability to work closely with external and internal customers.
• Strong attention to detail with the ability to manage multiple tasks and deadlines with accuracy.
• Ability to work both independently and collaboratively within a team environment.
• Customer focus

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 frequently required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. The employee must have excellent manual dexterity and fine motor skills to manipulate small objects, tools, and controls with precision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing 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 exposed to moving mechanical parts. The noise level in the work environment is usually moderate to loud. Employees are regularly exposed to moving mechanical parts, airborne particles, metal shavings, and fluids, which require consistent use of personal protective equipment (PPE).

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.