Overview
Quality Systems Manager Jobs in Boulder, Colorado, USA at Meddux
The QMS Manager is a dynamic, challenging, and high-impact role reporting directly to senior leadership. This position is integral to all aspects of the business, contributing to project teams, managing the document control process, and ensuring ISO and regulatory compliance of the QMS.
Essential Duties and Responsibilities:
Maintain the QMS to ensure compliance with ISO 13485 and 21 CFR 820.
Host audits of the QMS by customers and regulatory bodies.
Own the document control and training management processes.
Ensure the accuracy and completeness of documents and records for inclusion in DHFs / DHRs.
Collaborate on compliant and efficient strategies for reaching customer milestones.
Participate in Material Review Board activities and support the disposition of nonconforming inventory.
Support and coordinate the CAPA process.
Provide mentorship and leadership.
Identify opportunities for QMS and work process improvements.
Required Education, Experience, Skills, and Knowledge:
Minimum 7 years of professional experience, including medical device and manufacturing experience.
Document control experience required.
Strong understanding of ISO 13485 and 21 CFR 820, with a history of maintaining compliance.
Bachelor’s Degree in Engineering or a Technical Field preferred.
Excellent customer-facing communication skills.
Detail-oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP).
Willingness to learn and grow within the organization.
Customer-focused with excellent written and oral communication skills.
Salary Range:
$86,000 to $120,000 (based on Pay Scale data); bonus eligibility depends on company performance targets.
This position offers benefits including health, dental, vision, AD&D, Long-Term Disability Insurance, 401(k), and PTO starting at 15 days per year, increasing with service.
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Additional Information
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance
Industry: Medical Device
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Title: Quality Systems Manager
Company: Meddux
Location: Boulder, Colorado, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Engineering, Regulatory Compliance Specialist, Quality Technician/ Inspector)
