Associate Director, Quality Operations

Company: Sequel Med Tech
Location: Manchester
Posted on: March 12, 2025

Job Description:

About SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.Job OverviewThe Associate Director, Quality Assurance will be responsible for leading quality initiatives to support Sequel's transition into a Manufacturer of Record while maintaining compliance with FDA regulatory requirements, as well as support any expansion of Sequel into markets outside the US. This role will oversee key quality system processes, manage supplier quality management, and ensure product quality throughout its lifecycle. The ideal candidate will have direct experience in supporting on-market medical device quality assurance, a strong understanding of FDA and ISO regulations, and the ability to work cross-functionally in a dynamic startup environment. The scope of the role is expected to grow as Sequel's scope of activities might further evolve.Job Responsibilities and Essential DutiesEstablish Sequel as a Manufacturer of Record:

• Lead efforts to establish Sequel as the Manufacturer of Record, ensuring compliance with applicable FDA, ISO 13485, and other international regulatory requirements.
• Develop and implement the necessary quality system processes, documentation, and infrastructure to support Sequel's responsibilities.
• Collaborate with internal and external partners to ensure seamless integration of quality requirements into manufacturing and distribution processes.
• Serve as the primary quality liaison for critical suppliers, ensuring adherence to Sequel's quality standards.Quality System Leadership:
  • Oversee and maintain Sequel's Quality Management System (QMS) in compliance with FDA QSR (QMSR), ISO 13485, and other applicable regulatory requirements.
  • Lead and support internal and external audits, including FDA inspections, ISO audits, and supplier audits.
  • Drive continuous improvement initiatives to enhance the effectiveness of the QMS and ensure scalability for commercialization.
  • Ensure timely CAPA investigations, nonconformance management, and risk assessments to maintain product integrity and regulatory compliance.Supplier and Manufacturing Quality Oversight:
    • Develop and implement supplier qualification and monitoring programs, ensuring adherence to quality standards.
    • Partner with contract manufacturers and critical suppliers to ensure effective quality control processes, production validation, and regulatory compliance.
    • Manage corrective action processes and drive continuous improvement activities.Product Quality and Compliance:
      • Support post-market surveillance efforts, including complaint handling, product investigations, and risk mitigation.Cross-Functional Collaboration:
        • Provide quality training and mentorship to internal teams, ensuring compliance awareness and readiness for audits and inspections.
        • Lead and support change management initiatives to improve product and process quality.Minimum Requirements
          • Bachelor's degree in Engineering, Life Sciences, or related field preferred (Master's degree strongly preferred).
          • 10+ years of experience in medical device quality assurance, with at least 3 years in a leadership role.Required Knowledge, Skills and Abilities
            • Proven expertise in establishing and maintaining Quality Management Systems (QMS) compliant with FDA QSR (QMSR), ISO 13485, MDSAP, and other global regulations.
            • Strong experience with supplier quality management, contract manufacturing oversight, and risk-based quality strategies.
            • Demonstrated success in preparing for and hosting regulatory audits (FDA, ISO, Notified Bodies).
            • Knowledge of design control, risk management, post-market surveillance, and process validation.
            • Strong problem-solving skills, with a proactive and detail-oriented mindset.
            • Experience working in a startup or fast-growing company is highly desirable.
            • Excellent communication, collaboration, and leadership skills.Environmental/Safety/Physical Work Conditions
              • Ensures environmental consciousness and safe practices are exhibited in decisions.
              • Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
              • May work extended hours during peak business cycles.
              • Physical requirements such as lifting specific weights.
              • Some traveling is expected.
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Keywords: Sequel Med Tech, Manchester , Associate Director, Quality Operations, Executive , Manchester, New Hampshire