New · posted Nov 6
Nissha Medical Technologies · Medical Devices
Senior Quality Manager
- Colorado Springs, CO
- On-site
- Full-time
- Manager
The role
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.
What you need
- 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 Qualificationsnice to have
- 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
What you'll do
General:
- 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.
Pay and benefits
$125,000 – $150,000 a year
Employer providedThe 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.
Medical, dental, and vision coverage
401(k) with company match
Paid time off
Life and disability insurance
Professional development opportunities
Where you'll work
Colorado Springs, COOn-siteOpen in Maps (opens in a new tab)
More jobs in Colorado Springs, CO
From the posting
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.
Equal opportunity, accessibility and legal noticesNissha Medical Technologies's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Manager roles in the US17 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $125,000 | — | $150,000 |
| All US (middle half) | $143,500 | $159,000 | $165,500 |
This role: Nissha Medical Technologies's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 84 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Nissha Medical Technologies's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk9
- GMP and compliance7
- Collaboration and leadership7
- Documentation and SOPs4
- Investigations and CAPA2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulatorsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Nissha Medical Technologies on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 3
- Locations
By discipline
- Quality6 100%
By level
- Associate & Specialist3 50%
- Manager2 33%
- Senior & Principal1 17%
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Senior Quality Manager at Nissha Medical Technologies
Open until filled. $125K–$150K a year, employer provided.