Quality Engineer

ARCH•North Manchester, IN

11d

About The Position

ARCH Medical Solutions is seeking a Quality Engineer to support manufacturing quality and continuous improvement. The role works across manufacturing operations, customers, and production teams to investigate quality issues, validate processes and equipment, evaluate risk, and help ensure customer requirements are consistently met. The position includes hands-on involvement with manufacturing processes, inspections, quality systems, and technical problem-solving. The Quality Engineer serves as a technical quality resource, responds to customer questions, supports production through technical assistance and training, and contributes to quality planning, audits, corrective and preventive actions, and the accuracy of Device Master Records. The position performs assigned responsibilities in accordance with the ARCH Medical Grinding Quality Management System.

Requirements

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.

Nice To Haves

Experience with CMM operation, programming, or automated inspection techniques.

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.
Provide technical support and training to production teams.
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.