Director, Quality - Manchester, United States - Sequel Med Tech LLC

Description

About Sequel

Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview

As the Director of Quality at Sequel Med Tech, you will have a unique opportunity to shape the quality function of our organization from the ground up. You will lead the development, implementation, and continuous improvement of our quality management system, ensuring compliance with regulatory standards and industry best practices. This role requires a strategic thinker, a hands-on problem solver, and a collaborative leader who can work effectively with internal teams and external partners, including manufacturing and engineering.

Job Responsibilities and Essential Duties

• Quality Management System (QMS): Establish and oversee the development of a robust QMS that aligns with industry standards (e.g., ISO and regulatory requirements (e.g., FDA, CE Marking).
• Regulatory Compliance: Ensure that all quality processes and products meet or exceed relevant regulatory requirements and standards, including but not limited to FDA, ISO, and other global regulatory bodies.
• Quality Strategy: Collaborate with the VP, Quality to define the quality strategy for the organization and set clear objectives and key performance indicators (KPIs).
• Cross-Functional Collaboration: Work closely with engineering, manufacturing, and other internal and external teams to integrate quality considerations into product development, manufacturing, and supply chain processes.
• Supplier Quality Management: Develop and implement supplier quality management processes to ensure the quality of components and materials used in our medical devices.
• Risk Management: Lead risk management activities to identify, assess, and mitigate quality-related risks across the product lifecycle.
• Audits and Inspections: Prepare for and manage external audits and inspections by regulatory agencies and notified bodies.
• Continuous Improvement: Drive a culture of continuous improvement, implementing best practices and driving efficiency in quality processes.
• Team Leadership: Build and mentor a high-performing quality team, fostering a culture of accountability and excellence.
• Establish and lead the Change Management process
• CAPA - Corrective and Preventative Actions system
• Help setup Quality Control Operations for some Incoming Inspections
• Define and implement finished product release process
• Support HHE (Health and Hazard Evaluations), Recalls, FAA (Field Action Planning)
• Present to Management Review on Metrics (NCMRs, CAPAs, Supplier Quality, Audits, etc.)
• Support Customer Communication Processes establishment
• Support Supplier Audits and Supplier Monitoring

Minimum Requirements:

• Bachelor's degree in a relevant field preferred (Master's degree preferred).
• 8+ years of progressive quality management experience in the medical device industry.
• Experience leading and developing teams.

Required Knowledge, Skills and Abilities:

• In-depth knowledge of FDA regulations, ISO 13485, and other global quality standards.
• Proven track record of successfully implementing and managing quality management systems.
• Experience working with external manufacturing partners is a plus.
• Strong leadership, communication, and interpersonal skills.
• Excellent problem-solving and decision-making abilities.
• Able to lead within ambiguity and pivot quickly as priorities change within a rapidly growing startup environment.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.