Senior Quality Engineer - Medical Devices

Senior Quality Engineer – Medical Devices

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

INCOG are looking for an experienced Senior Quality Engineer, Medical Device to help build and strengthen their quality systems as they 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 INCOG’s medical device manufacturing projects, helping ensure patients get the treatments they need safely and on time.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

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

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

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.