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Quality Affairs Lead

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Blackrock Neurotech

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Location:
United States , Plymouth

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Quality Affairs Lead exists to build and own a lean, scalable Quality Management System that enables Adraxe to transition from early clinical success into full product development and commercialization of its Class III implantable neurostimulation system. This role is critical to ensuring design control rigor, DHF integrity, and regulatory readiness for IDE and eventual PMA, while effectively overseeing external partners and maintaining compliance without slowing execution. The impact is company-wide—de-risking the regulatory pathway, accelerating development timelines, and ensuring product safety and quality—directly supporting Adraxe’s mission to deliver breakthrough, minimally invasive neuromodulation therapies to patients. Success in the first 6–12 months looks like establishing a phase-appropriate QMS, achieving audit-ready design controls and risk management processes, supporting a strong IDE submission, and building the foundation for scalable quality operations and team growth.

Job Responsibility:

  • Own and execute Adraxe’s quality strategy by building and maintaining the QMS
  • Lead design controls and DHF integrity
  • Embed risk management across product development and clinical activities
  • Solve complex challenges around maintaining compliance without slowing execution
  • Manage quality across external partners
  • Prepare the company for FDA scrutiny and IDE/PMA milestones
  • Key initiatives include QMS build-out, IDE readiness, supplier qualification and QMAs, risk management implementation, and inspection readiness
  • Establish scalable post-market systems
  • Work cross-functionally with Engineering, Clinical, and Regulatory teams
  • Partner closely with leadership
  • Oversee external vendors such as CDMOs, design firms, and test labs

Requirements:

  • Deep expertise in medical device Quality Systems (QMS) and design controls for Class III devices
  • Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
  • Hands-on experience with DHF management, traceability, verification & validation
  • Supplier quality management, audits, and Quality Management Agreements (QMAs)
  • Inspection readiness, CAPA, nonconformance management, and internal auditing
  • Familiarity with IDE/PMA requirements and supporting regulatory submissions
  • Working knowledge of IEC 60601, IEC 62304, and ISO 10993
  • 10+ years in medical device quality or quality/regulatory or Quality Engineering roles
  • Direct experience with Class III and implantable devices (ideally neuromodulation)
  • Proven track record owning design controls and DHF in product development
  • Experience supporting IDE and/or PMA submissions
  • Strong background managing external partners (CDMOs, design firms, test labs)
  • Experience building or scaling quality systems in early-stage or fast-paced environments

Nice to have:

  • Prior experience leading or mentoring quality teams
  • Key behaviors aligned with our values: Ownership
  • Grit
  • Curiosity
  • Sound judgment
  • Adaptability
  • Collaboration

Additional Information:

Job Posted:
May 13, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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