Senior Quality Manager

Nissha•Colorado Springs, CO

7h•$125,000 - $150,000

About The Position

The Senior Quality Manager is the Quality Leader and Management Representative for Nissha Medical Technologies’ Colorado Springs site, accountable for the effectiveness, compliance, and continual improvement of the site Quality Management System. The role ensures that customer requirements, industry standards, company policies, and applicable regulations are met. The position leads maintenance and improvement of the Quality Management System, establishes and tracks Quality KPIs, develops department plans and budgets, leads site Management Reviews, and serves as the primary site Quality contact during MDSAP ISO 13485 audits, FDA inspections, and customer visits or audits. It also builds and leads the Quality organization, oversees quality control and assurance activities, complaints, CAPA, inspections, audits, and controlled documentation and records.

Requirements

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

Nice To Haves

CQE or CMQ/OE certification.
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.

Responsibilities

Follow company employee guidelines, Quality System Regulations, policies, and Standard Operating Procedures, and comply with applicable safety and security rules.
Maintain and continually improve the Quality Management System.
Establish and track 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 and audits.
Build and lead the Quality organization through clear objectives, coaching, performance management, workload prioritization, and development of technical and leadership capabilities.
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.
Ensure the site Quality Management System conforms to applicable requirements, including FDA Quality Management System Regulation, 21 CFR Part 820, ISO 13485:2016, and applicable customer, market, and regulatory requirements.
Oversee complaint handling and resolution of product-quality issues.
Oversee the CAPA process, including investigation quality, action planning, timely completion, and effectiveness verification.
Identify and implement process improvements.
Implement and ensure execution of inspection activities.
Manage the scheduling and execution of internal and external audits.
Govern site document and record control processes to ensure controlled information is accurate, approved, available, retained, and periodically reviewed.
Review, revise, and approve required documentation and procedures.