Quality Assurance Manager
$120,000–$140,000 year
On-siteLouisville, Colorado, United States
Job Summary
Coordinate the QA laboratory to deliver accurate, on-time quality control services while maintaining ISO 9001, ISO 13485, MDSAP, and ITAR compliance. Lead maintenance of the Quality Management System through internal auditing, document control, and root cause analysis for deviations. Oversee supplier audits and product acceptance processes, ensuring all records are accurate and staff knowledge of standards remains current. Schedule and conduct training sessions to ensure continued compliance with established quality standards. Exercise authority to halt production or shipments if quality requirements are not met. Fully onsite in Louisville, CO, with quarterly travel to the PA facility.
Required Qualifications
- A minimum 5 years of experience in Quality System management
- A minimum of 5 years experience maintaining an ISO 9001, ISO 13485 and MDSAP QMS
- A minimum of 3 years experience in conducting audits of an ISO 9001, ISO 13485 and MDSAP system
- Must demonstrate a working knowledge of ITAR restrictions, Technical Data protection, and restricted visitor protocols
- MS Office 3⁄4 Intermediate to Expert knowledge
- Excellent written and verbal communication skills
- Travel once a quarter to the facility in PA
Desired Qualifications
- Bachelors degree ideally in Engineering
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