Manufacturing Quality Engineer: Hands-On Problem Solver

ARCH; North Manchester (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

ARCH Medical Solutions is seeking a Quality Engineer who thrives on solving manufacturing problems, collaborating with customers and production teams, and turning quality data into meaningful improvements on the shop floor.

In this hands-on role you’ll help ensure processes, equipment, and test methods are capable and validated, investigate quality issues, and support corrective actions while working across quality, manufacturing, and supplier audits.

Qualifications

• Bachelor’s degree in a related discipline or equivalent experience.
• At least 3 years of related experience.
• Broad knowledge of FDA Quality System Regulations and ISO 13485.
• Strong understanding of mechanical inspection, shop math, and surface plate technology.
• Ability to read, interpret, and/or create engineering drawings, blueprints, and technical specifications.
• Intermediate to advanced knowledge of GD&T.
• Strong analytical, data collection, analysis, and presentation skills.
• Ability to communicate technical concepts clearly, both verbally and in writing.
• Strong computer skills, including proficiency with Microsoft Office.

Responsibilities

• Serve as a technical resource for quality across manufacturing operations.
• Respond to customer quality questions, investigate issues, and help determine and implement appropriate solutions.
• Partner with production teams by providing technical support and training.
• Support validation of manufacturing processes, equipment, and test methods.
• Evaluate manufacturing risks and help establish and maintain PFMEAs.
• Participate in contract reviews to evaluate quality requirements and manufacturing capabilities.
• Help ensure Device Master Records accurately reflect customer requirements, specifications, procedures, work instructions, and engineering drawings.
• Contribute to quality control plans, including in-process inspections and final acceptance activities.
• Conduct or support process capability studies and measurement system analysis.
• Help establish inspection methods, measurement tools, and appropriate inspection frequencies.
• Participate in internal and supplier audits.
• Investigate quality issues using root cause analysis and support corrective and preventive actions.
• Support receiving, first-piece, in-process, and final inspections as needed.
• Perform assigned responsibilities in accordance with the ARCH Medical Grinding Quality Management System.

Skills

Analytical skills

Data analysis

Engineering drawings

GD&T

Communication

Microsoft Office

Education

Bachelor’s degree in related discipline

Tools

CMM operation

CMM programming

Automated inspection

Job description

ARCH Medical Solutions is seeking a Quality Engineer who thrives on solving manufacturing problems, collaborating with customers and production teams, and turning quality data into meaningful improvements on the shop floor.

In this hands-on role you’ll help ensure processes, equipment, and test methods are capable and validated, investigate quality issues, and support corrective actions while working across quality, manufacturing, and supplier audits.