Job Description

Position Overview:

We are seeking a highly experienced and strategic Director of Corporate Quality in our Longmont, CO facility to lead and oversee our organization’s quality and regulatory compliance functions within the medical device industry. This critical leadership role is responsible for ensuring strong Quality Management System (QMS) compliance and enhancement, continuous improvement, and adherence to all applicable regulatory requirements (FDA, ISO 13485, MedAccred, etc.). The ideal candidate will have extensive experience managing QMS frameworks and regulatory compliance programs in a multi-site or corporate setting.

Key Responsibilities:

Quality Management Leadership:

• Define and execute the corporate quality strategy aligned with business goals and customer requirements.
• Ensure compliance with local, national, and international regulatory requirements, including FDA, ISO, EPA, and other industry-specific standards.
• Develop, implement, and maintain regulatory policies and procedures to align with industry best practices.
• Monitor changes in regulations and update internal processes accordingly.
• Oversee risk management activities in accordance with ISO 13485.
• Act as the company’s primary quality representative to key customers, regulatory bodies, and executive leadership.
• Lead internal audits, external audits, as well as third-party certification processes.
• Leads management review process and monitors quality objectives across both plants
• Maintain records of regulatory approvals, audits, and compliance activities.
• Prepare and submit regulatory reports as required by governing bodies.
• Work with suppliers to ensure regulatory compliance in raw materials and components used in injection molding.

Quality Control & Assurance:

• Oversee incoming inspection, in-process controls, final product release, and supplier quality activities.
• Implement and maintain robust process control systems, including validation (IQ/OQ/PQ), process monitoring, and quality metrics (KPIs).
• Coordinate Failure Mode and Effects Analysis (FMEA) and root cause analysis activities.
• Ensure timely resolution of customer quality issues, complaints, and non-conformances.
• Maintain strong relationships with key customers, providing regular updates on quality performance.
• Analyze quality metrics and KPIs to monitor plant performance and identify trends.

Continuous Improvement & Problem Solving:

• Champion continuous improvement initiatives using tools (CAPA, Risk Management, FMEA, SPC, Lean, Six Sigma).
• Drive quality improvement initiatives using Lean, Six Sigma, SPC, FMEA, and root cause analysis techniques.
• Standardize quality policies, procedures, and best practices across all facilities.
• Analyze quality metrics and KPIs to monitor plant performance and identify trends and opportunities for improvement
• Oversee and facilitate effective Corrective and Preventive Action (CAPA) processes to drive sustainable improvements and reduce future risk.
• Standardize quality policies, procedures, and best practices across both facilities.

Leadership & Team Development:

• Lead, mentor, and develop the corporate quality and regulatory compliance team.
• Foster a culture of compliance, quality excellence, and continuous improvement across all organizational levels.
• Provide regular reporting to executive leadership on quality metrics, regulatory updates, inspection outcomes, and risk management activities.

Qualifications:

• Bachelor’s degree in engineering, Quality or related field.
• 10+ years of progressive leadership experience in quality and compliance roles within the medical device industry.
• Deep knowledge of applicable regulations and standards: ISO 13485, FDA, and ISO 9001.
• Proven success managing regulatory inspections, audits, and certification processes.
• Strong expertise in CAPA, Risk Management, complaint handling, validation, and post-market surveillance.
• Proficiency in quality tools and methodologies: Lean, Six Sigma (Green or Black Belt preferred), FMEA, SPC, root cause analysis, etc.
• Exceptional leadership, communication, and stakeholder management skills.
• Experience working in a multi-site organization preferred.
• Willingness to travel domestically as required.

Preferred Certifications:

• Lead Auditor Certification (ISO 13485, ISO 9001, or similar)
• Six Sigma Green Belt or Black Belt
• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
• Certified Compliance & Ethics Professional (CCEP) or equivalent

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