Quality Engineer

ARCH•North Manchester, IN

25d

About The Position

ARCH Medical Solutions is seeking a Quality Engineer to help ensure manufacturing processes, equipment, and test methods are capable and validated; investigate quality issues; develop corrective actions; evaluate manufacturing risk; and strengthen systems that consistently meet customer requirements. The position involves hands-on work across the manufacturing process and collaboration with customers, production teams, quality, and manufacturing. The Quality Engineer serves as a technical resource for quality across manufacturing operations and 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.
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.