Quality Manager at New Deantronics

Sparks, Nevada, United States -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

115000.0

Posted On

18 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, FDA, ISO, Continuous Improvement, Six Sigma, CAPA, Root-Cause Analysis, Leadership, Cross-Functional Collaboration, Supplier Quality, Audit Management, Data-Driven Problem Solving, Quality Management System, Risk Management, Document Control, Validation

Industry

Medical Equipment Manufacturing

Description

Description About New Deantronics New Deantronics is a global medical device manufacturer with a strong reputation for quality, innovation, and precision. At our Sparks, NV facility, we’re growing a state-of-the-art operation focused on producing life-saving technologies. We believe in teamwork, safety, and technical excellence—and we’re looking for a Receptionist who shares those values. New Deantronics fosters a culture centered around its mission of "Caring", which extends to people, products, and the planet. This ethos is embedded in our operations across Taiwan and the United States, including our facility in Sparks, Nevada. Core Cultural Values Integrity & Professionalism: The company emphasizes honesty, integrity, and professionalism in all interactions. Teamwork & Friendliness: Collaboration and a friendly work environment are key components of their workplace culture. What We Offer 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 About the Role 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. What You'll Do 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. Requirements Knowledge, Skills, and Abilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. 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. Minimum Qualifications 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 Physical Demands While performing this job, the employee must be able to sit, stand, walk, bend, and use their hands regularly. The role also requires close and distance vision and the ability to adjust focus when working with computer equipment. The employee must be able to occasionally lift up to 20 pounds. The work environment typically has a low to moderate noise level.

Responsibilities

The Quality Manager is tasked with developing, implementing, and maintaining an effective Quality Management System (QMS) compliant with FDA regulations and ISO standards to ensure medical devices meet all safety and regulatory expectations. This involves leading internal and supplier audits, overseeing quality assurance across the device lifecycle, and mentoring quality personnel.