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Quality Engineer – Medical Device Manufacturing

Company Overview

Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture precision medical products including regulators, flowmeters, oxygen delivery components, and related respiratory equipment used by hospitals, EMS providers, fire departments, military organizations, and medical device OEMs.

We are seeking a qualified and motivated Quality Engineer to join our team and support our continued growth in the medical device industry.

Position Summary

The Quality Engineer will be responsible for supporting and maintaining Flotec’s quality management system, manufacturing quality controls, regulatory compliance activities, supplier quality processes, and continuous improvement initiatives. This position requires a strong working knowledge of medical device quality requirements, ISO 13485, FDA Quality System Regulations, corrective and preventive action systems, documentation control, inspection processes, and manufacturing support.

The ideal candidate will be detail-oriented, hands-on, comfortable working in a manufacturing environment, and capable of supporting both production and engineering teams.

Key Responsibilities

• Support and maintain compliance with ISO 13485, FDA QSR, and applicable medical device regulatory requirements.
• Assist with internal audits, supplier audits, customer audits, and third-party certification audits.
• Support CAPA investigations, root cause analysis, corrective actions, and effectiveness checks.
• Develop, review, and maintain quality procedures, work instructions, inspection plans, forms, and controlled documents.
• Support incoming inspection, in-process inspection, final inspection, and product release activities.
• Assist with nonconforming material reports, material review board activities, and disposition documentation.
• Review and approve engineering changes, production documentation, inspection records, and device history records.
• Support validation activities, including process validation, test method validation, equipment qualification, and production process improvements.
• Work with engineering and production teams to resolve quality issues and improve manufacturing processes.
• Support supplier quality activities, including supplier evaluations, corrective actions, and performance monitoring.
• Assist with risk management activities, including ISO 14971 documentation and product/process risk reviews.
• Support customer complaint investigations and returned product evaluations.
• Participate in continuous improvement projects focused on quality, efficiency, cost reduction, and compliance.
• Maintain accurate records in accordance with company procedures and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field preferred.
• Experience in medical device manufacturing or another regulated manufacturing environment.
• Working knowledge of ISO 13485 and FDA medical device quality system requirements.
• Experience with CAPA, nonconforming material, root cause analysis, document control, and internal audits.
• Ability to read and interpret engineering drawings, specifications, inspection requirements, and technical documentation.
• Strong written and verbal communication skills.
• Strong attention to detail and ability to maintain accurate records.
• Ability to work effectively with production, engineering, purchasing, and management teams.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Experience with FDA 21 CFR Part 820, ISO 14971, MDSAP, or other medical device regulatory frameworks.
• Experience with machining, assembly, pressure testing, oxygen equipment, or precision mechanical components.
• Experience with PPAP, FAI, process validation, equipment qualification, or supplier quality management.
• ASQ certification such as CQE, CQA, or Six Sigma certification is a plus.
• Experience supporting regulatory inspections or third-party certification audits.

Ideal Candidate

The ideal candidate is a practical, hands-on Quality Engineer who understands that quality is built into the process, not inspected in at the end. This person should be comfortable working directly with production personnel, inspectors, engineers, suppliers, and management to solve problems, improve processes, and maintain compliance in a medical device manufacturing environment.

Compensation and Benefits

Flotec offers competitive compensation based on experience and qualifications. Benefits may include paid time off, paid holidays, health insurance options, retirement plan participation, and opportunities for professional growth.

Schedule

Full-time position. Day shift. On-site position in Indianapolis, Indiana.

Work Location

Indianapolis, Indiana

Equal Opportunity Employer

Flotec is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.

How to Apply

Qualified candidates are encouraged to submit a resume and brief cover letter outlining their relevant quality engineering and medical device experience.