Quality Engineer

Arch-Medical-Solutions; North Manchester (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

ARCH Medical Solutions in Indiana seeks a hands-on Quality Engineer to build quality into manufacturing. You’ll work across production, customers, and suppliers to ensure processes, equipment, and test methods meet requirements and are validated.

You’ll investigate quality issues, develop corrective actions, perform root-cause analysis, and support PFMEAs, process capability studies, and inspections from receiving through final release.

Qualifications

• Bachelor’s degree or equivalent experience in a related field.
• Minimum 3 years of quality engineering in manufacturing.
• Knowledge of FDA QSR and ISO 13485 is preferred.
• Ability to read drawings and GD&T; strong analytical skills.

Responsibilities

• Serve as a technical resource for quality across manufacturing operations.
• Respond to customer quality questions, investigate issues, and implement solutions.
• Partner with production teams to provide training and technical support.
• Support validation of processes, equipment, and test methods.
• Evaluate risks and help establish PFMEAs.
• Participate in contract reviews to assess quality requirements.
• Ensure Device Master Records reflect customer needs and drawings.
• Contribute to quality control plans and inspection activities.
• Conduct or support process capability studies and MSAs.
• Develop inspection methods and frequency plans.
• Participate in internal and supplier audits.
• Investigate quality issues using RCA and support CAPA.
• Support receiving, in-process, and final inspections.
• Operate within ARCH Medical Grinding Quality Management System.

Skills

Quality engineering

Data analysis

Root cause analysis

Documentation

Communication

Education

Bachelor's degree in a related discipline

Tools

CMM

Microsoft Office

Job description

Description

Quality Engineer

ARCH Medical Solutions

Build Quality Into Products That Matter

We’re looking for a Quality Engineer who enjoys solving manufacturing problems, working directly with customers and production teams, and turning quality data into meaningful improvements.

In this role, you’ll have hands‑on involvement across the manufacturing process. You’ll help ensure processes, equipment, and test methods are capable and validated, investigate quality issues, develop corrective actions, evaluate manufacturing risk, and strengthen the systems that help us consistently meet customer requirements.

If you’re an analytical, hands‑on engineer who enjoys being close to the manufacturing floor and collaborating across teams, this could be a great next step.

What You’ll Do

• 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.

What We’re Looking For

• 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.

Even Better If You Have

Experience with CMM operation, programming, or automated inspection techniques is a plus.

Why This Role Stands Out

This isn’t a quality role that's isolated behind a desk. You'll have opportunities to work across quality, manufacturing, customers, and production, with direct involvement in problem‑solving, process capability, inspection strategy, manufacturing risk, and continuous quality improvement. This description reflects the cross‑functional responsibilities listed for the position.

Physical Requirements

The position includes standing and moving throughout the facility, periods of prolonged sitting and computer work, and lifting/carrying up to 50 pounds.

Equal Opportunity Employer

ARCH is an Equal Opportunity Employer and supports diversity in the workplace.

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.