Quality Manager

New Deantronics • Sparks, NV

just now

About The Position

The Quality Manager is responsible for developing, implementing, and sustaining an effective Quality Management System (QMS) that complies with FDA regulations, ISO standards, and internal company requirements. This role supports cross-functional teams to ensure that all medical devices meet regulatory, customer, and safety expectations.

Requirements

• Must demonstrate a high level of confidentiality and professionalism.
• Strong proficiency in Microsoft Office 365 applications.
• Exceptional interpersonal skills with the ability to communicate clearly and effectively in a calm and pleasant manner.
• Regulatory Compliance (FDA / ISO)
• Continuous Improvement / Six Sigma
• CAPA & Root-Cause Analysis
• Leadership & Cross-Functional Collaboration
• Supplier Quality & Audit Management
• Data-Driven Problem Solving
• Ability to read and write checklists, reports, and correspondence. Ability to read and comprehend complex instructions, memos, etc.
• Bachelor’s degree in Engineering, Quality Control, or similar field.
• 7+ years of progressive experience in medical device quality or another regulated industry.
• Demonstrated experience leading audits, managing QMS compliance, and guiding cross-functional teams.
• Strong knowledge of ISO processes.
• Proficiency in Quality Management systems

Responsibilities

• Develops, implements, and maintains the New Deantronics’ QMS in accordance with ISO and FDA requirements.
• Ensures ongoing regulatory compliance, including document control, validation, and risk-management processes.
• Leads internal audits, supplier audits, and supports regulatory inspections such as FDA audits.
• Manages quality assurance throughout the full device lifecycle including verification, validation, and post-market activities.
• Oversees inspection and testing processes to ensure all products meet required specifications.
• Leads and mentors quality personnel while fostering a strong culture of quality across all teams.
• Collaborates with engineering, manufacturing, supply chain, and regulatory teams to investigate and resolve quality issues
• Analyzes quality data, trends, and manufacturing metrics to identify root causes and drive continuous improvement.
• Recommends and implement process improvements to reduce defects and enhance compliance and efficiency.
• Maintains controlled quality documentation such as SOPs, work instructions, technical files, and audit reports.
• Performs related duties as required or directed by Executive Management.
• Maintains a safe and clean work environment.

Benefits

• Competitive pay and full benefits package - New Deantronics currently provides 100% employer-paid coverage for employee medical, dental, and vision insurance! We regularly review our benefits program to ensure long-term sustainability and competitiveness, so coverage levels may be subject to change.
• Opportunities for advancement in a growing organization
• Positive, team-oriented culture focused on safety and innovation
• Skill-building and certification support – We invest in YOU
• A chance to be a part of shaping the facility from the ground up

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level