Senior Quality Manager

Nissha Medical Technologies; Colorado Springs (CO); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

401(k) with company match

Paid time off

Job summary

Nissha Medical Technologies in Colorado Springs is seeking a Quality Leader and Management Representative to drive the site Quality Management System, ensure FDA QMS and ISO 13485 compliance, and lead continual improvement efforts. You will build a capable quality organization, oversee CAPA, audits, and KPI tracking, and partner with manufacturing to safeguard product quality.

Requires 8+ years in regulated medical devices and at least 4 years in leadership; CQE/CMQOe preferred.

Qualifications

• Bachelor’s degree in a relevant field.
• 8+ years of progressive quality experience in a medical device, pharmaceutical, life sciences, or another highly regulated manufacturing environment.
• 4+ years of leadership experience.

Responsibilities

• Oversee the site Quality Management System conforming to FDA QMSR, 21 CFR Part 820, ISO 13485:2016.
• Lead CAPA process, investigations, action planning, and effectiveness verification.
• Plan and lead audits, Management Reviews, and customer visits.
• Build and lead a capable quality organization with clear objectives and development opportunities.
• Ensure compliance with regulatory requirements and maintain document control.

Skills

Leadership

Quality Mgmt

ISO 13485

Regulatory Knowledge

Education

Bachelor's degree in a relevant field

Job description

About Nissha Medical Technologies
Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Job Description
About Nissha Medical Technologies
Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).
Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients’ lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.
At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you’re motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you’ll find a place to belong at NMT.
The primary responsibility of this position is to be the Quality Leader and Management Representative for the Colorado Springs site and is accountable for the effectiveness, compliance, and continual improvement of the Quality Management System.

General
What You Will Do

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and regulations are met.
• Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
• Abides by all safety and security rules set forth by the company and regulatory agencies
• Regular attendance is required.

Quality System

• Responsible for maintenance and ongoing improvement of the Quality Management System.
• Responsible for the establishment and tracking of Quality KPIs.
• Develop short and long-range Quality Department plans and budgets.
• Plan and lead site Management Reviews and support corporate Management Review activities, as applicable.
• Serve as the primary site Quality contact during MDSAP ISO 13485 audits, FDA inspections, and customer visits/audits.

Management

• Build and lead a capable, accountable Quality organization through clear objectives, coaching, performance management, workload prioritization, and development of technical and leadership capability.
• Recruit, onboard, train, and retain qualified Quality personnel in accordance with company policies and applicable employment requirements.
• Establish individual and team goals, conduct timely performance reviews, and create development opportunities that support departmental capability and career growth.

Quality Control And Quality Assurance

• Ensure the site Quality Management System conforms to applicable requirements, including FDA’s Quality Management System Regulation, 21 CFR Part 820, ISO 13485:2016, and other applicable customer, market, and regulatory requirements.
• Oversee the complaint-handling process and resolution of product-quality issues.
• Provide oversight of the CAPA process, including investigation quality, action planning, timely completion, and effectiveness verification.
• Identify and implement process improvements.
• Implement and ensure execution of all inspection activities.
• Manage the scheduling and execution of internal and external audits.

Documentation

• Provide governance and leadership for the site document and record control processes, ensuring controlled information is accurate, approved, available, retained, and periodically reviewed in accordance with applicable requirements.
• Reviews, revises, and approves required documentation and procedures.

What You Bring

Core Qualifications

• Bachelor’s degree in a relevant field
• A minimum of 8+ years of progressive quality experience in a medical device, pharmaceutical, life sciences, or another highly regulated manufacturing environment
• A minimum of 4 years of leadership experience

Preferred Qualifications

• CQE or CMQ/OE certification preferred
• Demonstrated ownership of an ISO 13485 compliant Quality Management System
• Working knowledge of FDA QMSR, 21 CFR Part 820, and applicable medical device quality requirements

Compensation & Benefits
The expected salary range for this position is $125,000 – $150,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.
In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.

Equal Opportunity Statement
Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.