Lead Quality Engineer for Combination Products

2 weeks ago

Cambridge, Massachusetts, United States Biogen Full time
Job Overview

Biogen is in search of an experienced Lead Quality Engineer specializing in Combination Products to join our Quality, Combination Products, and Devices team. This pivotal role will involve providing extensive quality oversight throughout the lifecycle of combination products. Your proficiency in design control, risk management, and human factors engineering will be essential in driving ongoing enhancement initiatives and ensuring adherence to both local and international regulations.

Key Responsibilities:

  • Serve as a Subject Matter Expert in combination products, advising the quality engineering team on pertinent matters.
  • Oversee the implementation of Design Control processes during all phases of product development.
  • Guarantee compliance with global quality standards by reviewing and endorsing technical documentation.
  • Direct R&D and manufacturing design processes to effectively apply Design Control principles.
  • Manage relationships with external device suppliers and testing partners, ensuring compliance with quality standards.
  • Lead initiatives for continuous improvement within the Quality Management System (QMS) for devices and combination products.
  • Support regulatory submissions and audits, acting as the final authority for quality approval on device-related sections.
  • Engage in internal and external audits and facilitate regulatory inspections.

Candidate Profile: You are a proactive R&D engineer with a strong focus on comprehensive quality engineering and risk management, possessing recognized expertise in the medical device, biopharmaceutical, and combination products sectors. Your innovative mindset and statistical proficiency enable you to adeptly navigate the complexities of device quality within the biotechnology landscape. You are driven to enhance Quality Management Systems (QMS) from a compliance-centric approach to a proactive business enabler that addresses the unmet needs of patients. You are acknowledged as a Subject Matter Expert with a proven track record in end-to-end Design Control, Risk Management, Post Market Surveillance, and Human Factors Engineering for intricate combination products.

Qualifications:

  • Bachelor's Degree in Engineering.
  • A minimum of 10 years of experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech sectors.
  • In-depth knowledge of Design Controls, cGMP, ISO 13485, QSR (21 CFR Part 820), and ISO standards.
  • Demonstrated success in verification & validation plans and translating user needs.
  • Strong understanding of Risk Management for combination products and medical devices.
  • Familiarity with statistical tools and validation/verification methodologies.
  • Proven experience in regulatory submissions and inspection facilitation.
  • Experience in a matrix organization with exceptional communication skills.
  • Strong project management, negotiation, and interpersonal abilities.

Preferred Qualifications:

  • Master's degree with 8+ years or a PhD with 4+ years of experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech sectors.
  • Experience with Class III medical devices.
  • Quality certifications (e.g., CQE, Six Sigma).
  • 1+ years of experience in people management.

Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established organization while promoting an environment where individual contributions are highly valued. Our team comprises some of the most talented and passionate professionals, providing unparalleled opportunities for learning, growth, and skill enhancement. Together, we strive to deliver transformative medicines, with every role being integral to our mission. We are committed to building a diverse and inclusive workforce that reflects the communities we serve, ensuring that every employee feels empowered and inspired.

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