Quality Manager

Based in Westminster, CO, we are a fast-growing company that manufactures a proprietary security system for people in need. We have been in business for over 30 years and are continuing to innovate our products.

We are seeking a dynamic and motivated Quality Manager to join our esteemed Engineering team. This is an opportunity to lead our efforts in launching ISO 13485 compliant practices to achieve our ISO 13485 certification.

• Competitive Base Salary!
• Chance to work with cutting-edge technology!
• Flexible Work Schedules!
• Accelerated Career Growth!
• Medical, dental, and vision benefits
• 401k

+ More!

Responsibilities:

As a Quality Manager, you will be entrusted with the following responsibilities:

1. Oversee and manage the entire Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and other applicable international regulatory requirements.
2. Develop, implement, and maintain quality management strategies and plans to ensure continuous improvements align with company objectives.
3. Lead the implementation of Lean/Six Sigma methodologies across the organization to promote a culture of continuous improvement.
4. Coordinate with internal and external auditors for ISO 13485 3rd party certification and maintain the ISO certified status of the organization.
5. Drive root cause analysis, corrective actions, and preventive actions for any non-conformances identified.
6. Monitor and manage risks to ensure product and process compliance with regulatory, quality, and performance standards.
7. Provide leadership and direction to the Quality team, fostering an environment that encourages employee participation, teamwork, and communication.
8. Prepare and present quality reports to the senior management team.

Qualifications:

To be successful in this role, you will need the following qualifications:

1. A Bachelor's degree in Engineering or a related field. A Master's degree will be considered an asset.
2. A minimum of 3 years of experience in Quality Management in the Engineering industry.
3. Proven experience with Lean/Six Sigma, ISO13485 3rd party certification, ISO13485, FDA compliance, and ISO certification.
4. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification is highly desirable.
5. Strong knowledge of quality management systems, methodologies, and best practices.
6. Excellent leadership skills with a demonstrated ability to lead a team and drive quality initiatives.
7. Exceptional problem-solving and analytical skills.
8. Excellent communication, interpersonal, and presentation skills.
9. Proficiency in using MS Office Suite and quality management software.

Join us in this challenging role to drive quality and continuous improvement in our organization. If you are passionate about quality management and have the required skills and experience, we would love to hear from you.