Director of Quality

1 week ago

Denver, United States EPM Scientific Full time

Company Summary: A leading medical device company is looking for a seasoned and ambitious leader to join its team as the Director of Quality. With their products far outperforming the competition, it is no surprise they hold a majority of the market share of the industry. Projections show them growing to a 2 billion dollar company by 2028, and a 4 billion dollar company over the next 10 years.



ESSENTIAL DUTIES


  • Recruitment and Team Management: Ensure timely recruitment of skilled team members, manage their development through training and cross-functional teams, and handle performance appraisals and salary administration.
  • Site Validation and Quality Assurance: Oversee site validation for new lines and process improvements, manage supplier and receiving quality assurance, and ensure production volume commitments are met while addressing non-conformances.
  • Quality Management System (QMS) Enhancement: Identify and address gaps in the QMS, develop metrics and mechanisms to improve NC/CAPA processes, and ensure audit and inspection readiness.
  • Collaboration and Issue Resolution: Collaborate with R&D to align product specifications with customer needs, support product complaint investigations, and resolve customer issues by addressing product, procedure, and policy problems.
  • Process Improvement and Compliance: Lead root cause analysis for complex issues, drive process improvements, ensure compliance with regulatory requirements, and serve as the Management Representative for FDA responsibilities.
  • Customer and Cross-functional Relationships: Develop and maintain constructive relationships with customers, operations, and other entities, facilitating the sharing of best practices and improving cross-functional processes.
  • Strategic Planning and Problem Solving: Continuously analyze changing business and customer needs, propose organizational or systems changes, and manage resources to resolve process, procedure, and policy problems effectively.


MINIMUM QUALIFICATION REQUIREMENTS


Education:

  • Bachelor's degree in Quality or a STEM-related discipline with 10+ years of experience, including 5 years of management experience, or a Master's degree in a related discipline.

Knowledge and Experience:

  • 10 years of experience with 5 years in management, or an equivalent combination of education and experience.
  • 5+ years of experience in a manufacturing environment with highly/fully automated processes, preferably in the medical device industry.
  • Demonstrated QMS and audit expertise for medical devices and combination products, with knowledge of applicable standards (e.g., ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
  • Extensive knowledge of U.S. and international medical device regulations and standards.
  • Understanding of quality management requirements and experience in developing quality goals and measures, and directing others, including R&D, suppliers, and process engineering.

Skills:

  1. Leadership and Relationship Building: Proven leadership and team development skills, strong interpersonal abilities to interface with senior management, and the capability to build and maintain effective relationships across functions and organizational levels.
  2. Strategic Planning and Project Management: Expertise in planning, budgeting, personnel development, project management, and applying manufacturing protocols and continuous improvement techniques to achieve business goals.
  3. Problem Solving and Customer Satisfaction: Positive, proactive approach to problem-solving, mentoring teams, diagnosing problems through analytical techniques, and implementing customer satisfaction measures for continuous improvement.

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