Senior Quality Engineer

2 weeks ago

Indianapolis, Indiana, United States Harba Solutions Inc. Full time $120,000 - $140,000 per year

Overview

A rapidly growing pharmaceutical and biologics manufacturer is expanding into the medical device combination product space and seeking a Senior Quality Engineer to help establish and enhance their quality systems. This position plays a key role in developing a world-class Quality Management System (QMS) aligned with FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR 2017/745 standards.

In this role, you'll support multiple product and client programs across U.S. and European markets—ensuring robust compliance, process control, and continuous improvement within an aseptic, GMP-regulated manufacturing environment. The position reports to the Director of Quality Systems and offers the opportunity to influence the design and integration of medical device quality programs within a growing organization.

Job Responsibilities

  • Design, implement, and maintain comprehensive quality management systems that meet FDA QSR, ISO 13485, and EU MDR requirements.
  • Develop and standardize SOPs, master quality manuals, and process documentation frameworks to support global regulatory compliance.
  • Establish scalable procedures to accommodate multiple clients and market requirements across the U.S. and EU.
  • Draft and manage quality and technical agreements defining client and manufacturer responsibilities for regulatory compliance.
  • Integrate design control and risk management principles (ISO into manufacturing and process development activities.
  • Lead and support internal and external quality system audits, ensuring inspection readiness and regulatory alignment.
  • Collaborate with validation, manufacturing, and technical services teams to ensure quality and risk management systems are applied throughout product introduction and lifecycle stages.
  • Support investigations, CAPAs, and continuous improvement initiatives across multiple production programs.
  • Provide technical documentation and QMS support for regulatory submissions to FDA, EMA, and Notified Bodies.
  • Manage change control activities to ensure technical accuracy and compliance for device-related products.

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline (advanced degree preferred).
  • 6+ years of experience in medical device or combination product quality systems.
  • Proven experience with FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745 implementation and maintenance.
  • Familiarity with EMA guidance documents, MDCG guidelines, and Notified Body requirements.
  • Understanding of ISO 14971 risk management and application within device manufacturing.
  • Experience supporting CE marking processes and technical documentation.
  • Strong collaboration and communication skills, with experience managing quality relationships across diverse regulatory environments.
  • Experience in contract manufacturing (CMO/CDMO) environments is preferred.

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