Senior Quality Engineer, Medical Device

INCOG is a leading provider of aseptic filling services for a wide range of life-saving products. As we expand our capabilities to include drug (or biologic) and medical device combination products, such as autoinjectors; we’re closing a key gap in the GMP manufacturing ecosystem and helping ensure patients receive critical medicines faster and more reliably.

We’re looking for an experienced Senior Quality Engineer, Medical Device to help build and strengthen our quality systems as we grow into this exciting new space. In this role, you’ll be responsible for developing, implementing, and maintaining a world-class quality management system that meets FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR 2017/745 requirements.

Reporting to the Director of Quality Systems, you’ll serve as a subject matter expert supporting multiple client programs across U.S. and European markets. Your work will directly impact the reliability, compliance, and success of our medical device manufacturing projects, helping ensure patients get the treatments they need safely and on time.

Essential Job Functions:

• Design, develop, and implement comprehensive facility-wide quality management systems compliant with FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745
• Establish scalable quality system procedures adaptable to multiple client requirements across US, European, and global markets
• Create and maintain master quality manuals, SOPs, and process documentation frameworks supporting contract manufacturing for both FDA and EMA regulated products
• Develop client-specific quality agreements and technical agreements outlining quality responsibilities for US and EU market requirements
• Implement design controls and manufacturing quality systems accommodating FDA QSR and EU MDR specifications
• Conduct quality system assessments, and work with outside auditors, to demonstrate FDA, ISO 13485, and EU MDR compliance capabilities
• Develop quality risk assessments incorporating ISO 14971 and EU MDR risk management requirements
• Work with other technical functions, such as technical services, validation, and manufacturing, to ensure that medical device manufacturing risk management and QSR principles are implemented during product introduction.
• Provide technical quality support for investigations, continuous improvement, and other routine production activities for multiple products
  
  

Special Job Requirements:

• Bachelor's degree in Engineering, Life Sciences, or related technical field; advanced degree in regulatory, quality, or sciences preferred.
• Minimum 5-7 years of experience in medical device quality systems
• Experience managing quality systems for US and European market compliance
• Thorough knowledge of FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745
• Understanding of EMA guidance documents, MDCG guidelines, and Notified Body requirements
• Experience with CE marking processes, technical documentation, and authorized representative relationships
• Understanding of ISO 14971 risk management principles and practices
• Excellent client relationship management across different regulatory cultures
• Support client regulatory submissions by providing CMO quality system documentation for FDA, EMA, and Notified Body requirements
• Ensure change controls for medical device products are technically correct and managed within the INCOG change control system
  
  

Additional Preferences:

• 3+ years of contract manufacturing or CMO experience preferred
• Direct experience implementing FDA QSR, ISO 13485, and EU MDR requirements
  
  

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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