Senior Quality Manager

Nissha Medical Technologies•Colorado Springs, CO

About The Position

The Senior Quality Manager is the Quality Leader and Management Representative for Nissha Medical Technologies’ Colorado Springs site. The role is accountable for the effectiveness, compliance, and continual improvement of the site Quality Management System (QMS). The manager leads the Quality organization, develops departmental plans and budgets, and ensures the site meets applicable customer, industry, and regulatory requirements. The position oversees QMS maintenance and improvement, quality metrics, management reviews, audits and inspections, complaint handling, CAPA, inspection activities, and controlled documentation and records. The Senior Quality Manager serves as the primary site Quality contact during MDSAP and ISO 13485 audits, FDA inspections, and customer visits or audits. The role also recruits, develops, and manages qualified Quality personnel.

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 Nissha Medical Technologies employee guidelines, Quality System Regulations, policies, and Standard Operating Procedures to help ensure customer requirements and applicable standards and regulations are met.
Act in accordance with NMT’s Employee Guidelines and applicable quality standards in the Quality Manual, and follow company and regulatory safety and security rules.
Maintain and continually improve the site 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 and ISO 13485 audits, FDA inspections, and customer visits and audits.
Build and lead an accountable Quality organization through clear objectives, coaching, performance management, workload prioritization, and staff development.
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 QMS conforms to applicable requirements, including FDA QMSR, 21 CFR Part 820, ISO 13485:2016, and other applicable customer, market, and regulatory requirements.
Oversee complaint handling and resolution of product-quality issues.
Provide oversight of CAPA investigations, 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.
Provide governance and leadership for site document and record control processes, ensuring controlled information is accurate, approved, available, retained, and periodically reviewed.
Review, revise, and approve required documentation and procedures.
Maintain regular attendance.