Director of Quality – Broomfield, CO
Type: Direct Hire
Shift: M-F, 1st, Hybrid (3/2)
Salary: 110-150K DOE
Role and Responsibilities:
- Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with CAP, ISO15189:2012, and regulatory requirements.
- Prepare reports and conduct Management Review Meetings to assess quality and performance.
- Coordinate the Corrective and Preventive Action (CAPA) process, managing nonconformities and ensuring timely resolution.
- Oversee Internal Quality Assessments, Interim Self-Inspections, and external audits, including CAP and ISO assessments, and customer audits.
- Manage the vendor system to ensure effective control and surveillance of critical suppliers of materials and services.
- Ensure personnel are properly trained on QMS procedures and maintain accurate training documentation.
- Review and resolve complaints and ensure adherence to regulatory requirements.
- Monitor test performance and equipment validations, calibrations, and preventive maintenance, ensuring compliance with established performance specifications.
- Oversee document change orders, ensuring quality and compliance throughout the process.
- Allocate resources, administer laboratory services, and manage budget planning, while providing ongoing education on CLIA compliance.
Qualifications
- Minimum of five (5) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry plus a Bachelor's Degree
- -OR-
- A minimum of seven (7) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry.
- Strong communication and leadership skills
- Ability to investigate and resolve quality problems
- Strong auditing knowledge and experience is also required.
Additional Notes:
- This is a hybrid position requiring on-site presence for three days a week, with the ability to work remotely two days a week. A remote work policy agreement will be signed by the employee and their manager.
